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A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Primary Purpose

Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TAK-007

Chemotherapy Agents

About this trial

This is an interventional treatment trial for Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) focused on measuring Drug Therapy, Chimeric antigen receptor, Natural killer cells, Cell therapy, Allogeneic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants who have a life expectancy ≥12 weeks.
Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing disease of the following types:
a. LBCL, including the following subtypes defined by the World Health Organization (WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii. High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii. HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular lymphoma (FL) or marginal zone lymphoma (MZL).
v. T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii. Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix. Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal, extranodal, and splenic).
Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography -positive disease per the Lugano classification.
Participants whose disease is r/r after at least 2 prior lines of systemic therapy:
1. Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody (mAb) and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
2. Participants with iNHL must have received an anti-CD20 mAb and an alkylating agent (eg, bendamustine or cyclophosphamide).
3. Preinduction salvage chemotherapy and ASCT should be considered 1 therapy.
4. Any consolidation/maintenance therapy after a chemotherapy regimen (without intervening relapse) should be considered 1 line of therapy with the preceding combination therapy. Maintenance antibody therapy should not be considered a line of therapy.
5. Single-agent anti-CD20 mAb therapy should not be considered a line of therapy.
Participants who have adequate bone marrow function defined as follows:
1. Absolute neutrophil count >500/μL.
2. Platelet count of >50,000/μL at screening. Participants with transfusion-dependent thrombocytopenia are excluded.
Participants who have adequate renal, hepatic, cardiac, and pulmonary function as defined in the study protocol:
1. Estimated glomerular filtration rate (GFR; Modification of Diet in Renal Disease equation [MDRD]) ≥30 mL/min.
2. Serum alanine aminotransferase/aspartate aminotransferase ≤5 times the upper limit of normal range (ULN), as long as participant is asymptomatic.
3. Total bilirubin ≤2 mg/dL. Participants with Gilbert's syndrome may have a bilirubin level >2 × ULN, per discussion between the investigator and the medical monitor.
4. Left ventricular ejection fraction (LVEF) ≥40% as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month of determination of eligibility.
5. No evidence of clinically relevant pericardial effusion, and no acute clinically significant electrocardiogram (ECG) findings.
6. Absence of Grade ≥2 pleural effusion. Grade 1 stable pleural effusions are allowed.
7. Baseline oxygen saturation >92% on room air.
Participants are required to consent to provide either sufficient archived formalin-fixed paraffin embedded (at least 10 unstained slides, ideally 20 unstained slides) or fresh tumor tissue obtained after the last relapse (see laboratory manual for details). Exception may be granted by sponsor medical monitor per discussion with investigator.

Exclusion Criteria:

Participants with total body weight of <40 kg.
Participants with primary or secondary central nervous system (CNS) involvement by lymphoma. Participants with a history of secondary CNS involvement by lymphoma without evidence of CNS involvement at screening may be included.
Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma, or transformation from CLL/small lymphocytic lymphoma (Richter transformation).
Participants with a history of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed gastric cancer) or unless disease free for ≥3 years at screening.
Participants who have undergone autologous or allogeneic transplant or Chimeric antigen receptor T cells (CAR-T) therapy within 3 months of planned enrollment. Participants after allogeneic transplant have to be off systemic immunosuppressive therapy and without the evidence of clinically relevant acute or chronic graft-versus-host disease (GvHD) at the time of enrollment.
Treatment with any investigational products or any systemic anticancer treatment within 14 days or 2 half-lives of the treatment (whichever is longer) before conditioning therapy.
Participants with active infection, including fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management within 3 days before enrollment.
Participants with a history or presence of active or clinically relevant CNS disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, severe dementia, cerebellar disease, or any autoimmune disease with CNS involvement. For CNS disorders that recover or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
Participants with any of the following within 6 months of enrollment: myocardial infarction, cardiac angioplasty or stenting, unstable angina, symptomatic congestive heart failure (ie, New York Heart Association Class II or greater), clinically significant arrythmia (including uncontrolled atrial fibrillation), or any other clinically significant cardiac disease.
Participants who have received a live vaccine ≤6 weeks before the start of the conditioning regimen.

Sites / Locations

University of Alabama at BirminghamRecruiting
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteRecruiting
MedStar Georgetown University Medical CenterRecruiting
Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics
Northside HospitalRecruiting
Northwestern Memorial HospitalRecruiting
University of Michigan Comprehensive Cancer CenterRecruiting
Montefiore Medical Center
Columbia University Medical CenterRecruiting
DUHS Duke Blood Cancer CenterRecruiting
Oregon Health and Science UniversityRecruiting
Thomas Jefferson University Sidney Kimmer Cancer Center, Clinical Research OrganizationRecruiting
Saint Davids South Austin Medical CenterRecruiting
University of Texas MD Anderson Cancer CenterRecruiting
University of Virginia Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells

Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells

Part 1: Dose Expansion: LBCL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells

Part 1: Dose Expansion: iNHL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells

Part 2: Cohort 1- LBCL

Part 2: Cohort 2- iNHL

Arm Description

Participants will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 200×10^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable natural killer (NK) cells, single-dose, intravenously, once on Day 0.

Participants will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0.

Participants with r/r Large B-cell Lymphoma (LBCL) will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0 to determine RP2D.

Participants with r/r Indolent Non-Hodgkin Lymphoma (iNHL) will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0 to determine RP2D.

Participants with LBCL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.

Participants with iNHL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Adverse Events (AEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

Part 1: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Laboratory parameters will include hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

Part 1: Number of Participants with Clinically Significant Changes in Vital Signs

Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse rate (bpm).

Part 2: Overall Response Rate (ORR) per Independent Review Committee (IRC)

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as best response to treatment, determined by the IRC per the Lugano 2014 criteria after TAK-007 administration.

Secondary Outcome Measures

Part 1 and Part 2: ORR per Investigator

ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration.

Part 1 and Part 2: Complete Response (CR) per Investigator

CR will be defined per Lugano 2014 criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease.

Part 2: Complete Response (CR) Per IRC

CR will be defined per Lugano criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease.

Part 1 and Part 2: Duration of Response (DOR) per Investigator

DOR is defined as the time from the date of first documented objective response to the date of first documented disease progression, determined by investigator per Lugano 2014 criteria classification or death, whichever comes first, for participants who experience an objective response.

Part 2: Duration of Response (DOR) per IRC

DOR is defined as the time from the date of first documented objective response to the date of first documented disease progression, determined by the IRC Lugano 2014 criteria classification or death, whichever comes first, for participants who experience an objective response.

Part 1 and Part 2: Progression-free Survival (PFS) per Investigator

PFS is defined as time from enrollment date to the date of disease progression, determined by the investigator per Lugano 2014 criteria classification or death from any cause, whichever comes first.

Part 2: Progression-free Survival (PFS) per IRC

PFS is defined as time from enrollment date to the date of disease progression, determined by the IRC per Lugano 2014 criteria classification or death from any cause, whichever comes first.

Parts 1 and 2: Overall Survival (OS)

OS is defined as time from enrollment to the date of death from any cause.

Part 2: Number of Participants with Adverse Events (AEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Laboratory parameters will include hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

Part 2: Number of Participants with Clinically Significant Changes in Vital Signs

Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).

Parts 1 and 2: Cmax - Maximum Observed Blood Concentration of TAK-007

Parts 1 and 2: Tmax - Time of First Occurrence of Cmax of TAK-007

Parts 1 and 2: Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007

Parts 1 and 2: AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007

Part 1 and Part 2: Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time

Concentration of IL-15 and soluble immune factors (eg, Interferon (IFN)-gamma (γ), IL-1 beta (β), IL- 2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, Tumor necrosis factor (TNF) alpha (α), Granulocyte-macrophage colony-stimulating factor (GM-CSF)) in plasma over time will be reported.

Percentage of Participants with B-cell Aplasia Before and After TAK-007 Administration

Percentage of Participants with Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time

Percentage of Participants with Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time

Full Information

NCT ID

NCT05020015

First Posted

August 20, 2021

Last Updated

August 17, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT05020015

Brief Title

A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Official Title

A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 22, 2021 (Actual)

Primary Completion Date

October 26, 2029 (Anticipated)

Study Completion Date

October 26, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma. The main aim of Part 2 is to learn if lymphomas are reduced or gone after treatment withTAK-007 in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma or indolent non-Hodgkin lymphoma (iNHL). Participants will receive lymphodepleting chemotherapy for 3 days before receiving a single injection of TAK-007. After this, participants will regularly visit the clinic for check-ups.

Detailed Description

The product being tested in this study is called TAK-007. TAK-007 is being tested to evaluate the safety and tolerability in adult participants with r/r B-cell NHL. The study will include 2 parts: Part 1 (Dose escalation and dose expansion) and Part 2. The study will enroll approximately 242 patients. In Part 1, dose escalation and dose expansion cohorts participants will receive TAK-007 as follows: Part 1: Dose escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells (±30%) Part 1: Dose escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells (±25%) Part 1: Dose expansion: r/r LBCL: TAK-007 - 200×10^6/800×10^6 Viable NK Cells Part 1: Dose expansion: r/r iNHL: TAK-007 - 200×10^6/ 800×10^6 Viable NK Cells Based on the data in Part 1, a single TAK-007 dose level will be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D). Once RP2D is determined, participants will be enrolled in Part 2 of the study in the following cohorts: Cohort 1: TAK-007 (LBCL) Cohort 2: TAK-007 (iNHL) This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic and will enroll in a separate, long-term, follow-up study for continued safety assessments for up to 15 years after TAK-007 administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Keywords

Drug Therapy, Chimeric antigen receptor, Natural killer cells, Cell therapy, Allogeneic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This study has 2 Parts: Part 1 is composed of dose escalation followed by dose expansion and Part 2.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells

Arm Type

Experimental

Arm Description

Participants will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0.

Arm Title

Part 1: Dose Expansion: LBCL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Dose Expansion: iNHL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells

Arm Type

Experimental

Arm Description

Arm Title

Part 2: Cohort 1- LBCL

Arm Type

Experimental

Arm Description

Participants with LBCL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.

Arm Title

Part 2: Cohort 2- iNHL

Arm Type

Experimental

Arm Description

Participants with iNHL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.

Intervention Type

Biological

Intervention Name(s)

TAK-007

Intervention Description

TAK-007 intravenous injection.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy Agents

Intervention Description

Fludarabine and cyclophosphamide as per standard of care.

Primary Outcome Measure Information:

Title

Part 1: Number of Participants with Adverse Events (AEs)

Description

Time Frame

Up to 60 months

Title

Part 1: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Description

Laboratory parameters will include hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

Time Frame

Up to 60 months

Title

Part 1: Number of Participants with Clinically Significant Changes in Vital Signs

Description

Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse rate (bpm).

Time Frame

Up to 60 months

Title

Part 2: Overall Response Rate (ORR) per Independent Review Committee (IRC)

Description

Time Frame

Up to 60 months

Secondary Outcome Measure Information:

Title

Part 1 and Part 2: ORR per Investigator

Description

ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration.

Time Frame

Up to 60 months

Title

Part 1 and Part 2: Complete Response (CR) per Investigator

Description

Time Frame

Up to 60 months

Title

Part 2: Complete Response (CR) Per IRC

Description

Time Frame

Up to 60 months

Title

Part 1 and Part 2: Duration of Response (DOR) per Investigator

Description

Time Frame

Up to 60 months

Title

Part 2: Duration of Response (DOR) per IRC

Description

Time Frame

Up to 60 months

Title

Part 1 and Part 2: Progression-free Survival (PFS) per Investigator

Description

PFS is defined as time from enrollment date to the date of disease progression, determined by the investigator per Lugano 2014 criteria classification or death from any cause, whichever comes first.

Time Frame

Up to 60 months

Title

Part 2: Progression-free Survival (PFS) per IRC

Description

PFS is defined as time from enrollment date to the date of disease progression, determined by the IRC per Lugano 2014 criteria classification or death from any cause, whichever comes first.

Time Frame

Up to 60 months

Title

Parts 1 and 2: Overall Survival (OS)

Description

OS is defined as time from enrollment to the date of death from any cause.

Time Frame

Up to 60 months

Title

Part 2: Number of Participants with Adverse Events (AEs)

Description

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

Time Frame

Up to 60 months

Title

Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Description

Laboratory parameters will include hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

Time Frame

Up to 60 months

Title

Part 2: Number of Participants with Clinically Significant Changes in Vital Signs

Description

Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).

Time Frame

Up to 60 months

Title

Parts 1 and 2: Cmax - Maximum Observed Blood Concentration of TAK-007

Time Frame

Predose (Day 0) and at multiple timepoints postdose (up to 60 months)

Title

Parts 1 and 2: Tmax - Time of First Occurrence of Cmax of TAK-007

Time Frame

Predose (Day 0) and at multiple timepoints postdose (up to 60 months)

Title

Parts 1 and 2: Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007

Time Frame

Predose (Day 0) and at multiple timepoints postdose (up to 60 months)

Title

Parts 1 and 2: AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007

Time Frame

Predose (Day 0) and at multiple timepoints postdose (up to 60 months)

Title

Part 1 and Part 2: Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time

Description

Time Frame

Up to 24 months

Title

Percentage of Participants with B-cell Aplasia Before and After TAK-007 Administration

Time Frame

Up to 24 months

Title

Time Frame

Up to 24 months

Title

Percentage of Participants with Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time

Time Frame

Up to 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who have a life expectancy ≥12 weeks. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing disease of the following types: a. LBCL, including the following subtypes defined by the World Health Organization (WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii. High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii. HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular lymphoma (FL) or marginal zone lymphoma (MZL). v. T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii. Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix. Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal, extranodal, and splenic). Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography -positive disease per the Lugano classification. Participants whose disease is r/r after at least 2 prior lines of systemic therapy: Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody (mAb) and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT). Participants with iNHL must have received an anti-CD20 mAb and an alkylating agent (eg, bendamustine or cyclophosphamide). Preinduction salvage chemotherapy and ASCT should be considered 1 therapy. Any consolidation/maintenance therapy after a chemotherapy regimen (without intervening relapse) should be considered 1 line of therapy with the preceding combination therapy. Maintenance antibody therapy should not be considered a line of therapy. Single-agent anti-CD20 mAb therapy should not be considered a line of therapy. Participants who have adequate bone marrow function defined as follows: Absolute neutrophil count >500/μL. Platelet count of >50,000/μL at screening. Participants with transfusion-dependent thrombocytopenia are excluded. Participants who have adequate renal, hepatic, cardiac, and pulmonary function as defined in the study protocol: Estimated glomerular filtration rate (GFR; Modification of Diet in Renal Disease equation [MDRD]) ≥30 mL/min. Serum alanine aminotransferase/aspartate aminotransferase ≤5 times the upper limit of normal range (ULN), as long as participant is asymptomatic. Total bilirubin ≤2 mg/dL. Participants with Gilbert's syndrome may have a bilirubin level >2 × ULN, per discussion between the investigator and the medical monitor. Left ventricular ejection fraction (LVEF) ≥40% as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month of determination of eligibility. No evidence of clinically relevant pericardial effusion, and no acute clinically significant electrocardiogram (ECG) findings. Absence of Grade ≥2 pleural effusion. Grade 1 stable pleural effusions are allowed. Baseline oxygen saturation >92% on room air. Participants are required to consent to provide either sufficient archived formalin-fixed paraffin embedded (at least 10 unstained slides, ideally 20 unstained slides) or fresh tumor tissue obtained after the last relapse (see laboratory manual for details). Exception may be granted by sponsor medical monitor per discussion with investigator. Exclusion Criteria: Participants with total body weight of <40 kg. Participants with primary or secondary central nervous system (CNS) involvement by lymphoma. Participants with a history of secondary CNS involvement by lymphoma without evidence of CNS involvement at screening may be included. Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma, or transformation from CLL/small lymphocytic lymphoma (Richter transformation). Participants with a history of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed gastric cancer) or unless disease free for ≥3 years at screening. Participants who have undergone autologous or allogeneic transplant or Chimeric antigen receptor T cells (CAR-T) therapy within 3 months of planned enrollment. Participants after allogeneic transplant have to be off systemic immunosuppressive therapy and without the evidence of clinically relevant acute or chronic graft-versus-host disease (GvHD) at the time of enrollment. Treatment with any investigational products or any systemic anticancer treatment within 14 days or 2 half-lives of the treatment (whichever is longer) before conditioning therapy. Participants with active infection, including fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management within 3 days before enrollment. Participants with a history or presence of active or clinically relevant CNS disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, severe dementia, cerebellar disease, or any autoimmune disease with CNS involvement. For CNS disorders that recover or are in remission, participants without recurrence within 2 years of planned study enrollment may be included. Participants with any of the following within 6 months of enrollment: myocardial infarction, cardiac angioplasty or stenting, unstable angina, symptomatic congestive heart failure (ie, New York Heart Association Class II or greater), clinically significant arrythmia (including uncontrolled atrial fibrillation), or any other clinically significant cardiac disease. Participants who have received a live vaccine ≤6 weeks before the start of the conditioning regimen.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Takeda Contact

Phone

+1-877-825-3327

medinfoUS@takeda.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

205-996-8400

amitkumarmehta@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Amitkumar Mehta

Facility Name

Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

310-423-1281

justin.darrah@cshs.org

First Name & Middle Initial & Last Name & Degree

Justin Darrah

Facility Name

MedStar Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

202-444-3736

Pashna.N.Munshi@gunet.georgetown.edu

First Name & Middle Initial & Last Name & Degree

Pashna Munshi

Facility Name

Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Northside Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

404-851-8238

ssolomon@bmtga.com

First Name & Middle Initial & Last Name & Degree

Scott Solomon

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

312-942-5157

reem.karmali@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Reem Karmali

Facility Name

University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

734-793-6878

Ext

ghoshm@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Monalisa Ghosh

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

215-342-0530

rr3036@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Ran Reshef

Facility Name

DUHS Duke Blood Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

919-668-1000

ahmed.galal@duke.edu

First Name & Middle Initial & Last Name & Degree

Ahmed Galal

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

503-494-8945

saultzje@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Saultz

Facility Name

Thomas Jefferson University Sidney Kimmer Cancer Center, Clinical Research Organization

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

215-955-4367

Usama.Gergis@jefferson.edu

First Name & Middle Initial & Last Name & Degree

Usama Gergis

Facility Name

Saint Davids South Austin Medical Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78704

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

512-816-8611

Shahbaz.Malik@hcahealthcare.com

First Name & Middle Initial & Last Name & Degree

Shahbaz Malik

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

713-745-4017

lnastoupil@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Loretta Nastoupil

Facility Name

University of Virginia Comprehensive Cancer Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

434-924-9333

iv8mm@hscmail.mcc.virginia.edu

First Name & Middle Initial & Last Name & Degree

Indumathy Varadarajan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Links:

URL

https://clinicaltrials.takeda.com/study-detail/612723b3ca0ce2002ab9e667

Description

To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

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