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Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (LuminICE-203)

Primary Purpose

Relapsed or Refractory Hodgkin Lymphoma, Peripheral T Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AFM13
AB-101
Cyclophosphamide
Fludarabine
Interleukin-2
Sponsored by
Affimed GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Hodgkin Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes: PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative) Subjects with R/R classical HL must have received at least two lines of therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor. Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin. Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment. Ability to understand and sign the ICF Exclusion Criteria: Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid) Previous treatment with AFM13 or CBNK cells History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents Treatment with any therapeutic mAb or immunosuppressive medications Known active Hepatitis B or C defined per protocol Active HIV Infection History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction

Sites / Locations

  • City of Hope National Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Safety run-in in Hodgkin Lymphoma

Dose Level A in Hodgkin Lymphoma

Dose Level B in Hodgkin Lymphoma

Exploratory: AFM13 + AB-101 on CD30-positive PTCL

Arm Description

4 safety run-in cohorts: Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)

AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)

Outcomes

Primary Outcome Measures

Objective Response Rate by Independent Radiology Committee
ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification

Secondary Outcome Measures

Duration of Response by Investigator and Independent Radiology Committee
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
Complete response rate (CRR) by Investigator and Independent Radiology Committee
Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
ORR by Investigator based on PET-CT as assessed by the Lugano classification
ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
Incidence of subjects receiving subsequent transplant
The incidence of subjects receiving subsequent transplant will be assessed and summarized by percentage rates and 95% Confidence Intervals
Incidence of TEAEs and SAEs
Frequency of subjects with study-drug related treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Immunogenicity assessment of AFM13 in combination with AB-101
Frequency of subjects developing anti-drug antibodies (ADAs) against AFM13 or AB-101
Progression-free survival (PFS) by Independent Radiology Committee
Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until PD/OS.
Overall survival (OS)
Overall survival rate

Full Information

First Posted
May 19, 2023
Last Updated
October 12, 2023
Sponsor
Affimed GmbH
Collaborators
Artiva Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05883449
Brief Title
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
Acronym
LuminICE-203
Official Title
A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affimed GmbH
Collaborators
Artiva Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
Detailed Description
The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and 4 will start only if the combination treatment has been well tolerated. Following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical HL and will follow a Simon two-stage design. An additional exploratory cohort (Cohort 5) will enroll subjects with select CD30-positive PTCL subtypes after completion of the safety run-in. All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is 48-days).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hodgkin Lymphoma, Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety run-in in Hodgkin Lymphoma
Arm Type
Experimental
Arm Description
4 safety run-in cohorts: Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)
Arm Title
Dose Level A in Hodgkin Lymphoma
Arm Type
Experimental
Arm Description
Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)
Arm Title
Dose Level B in Hodgkin Lymphoma
Arm Type
Experimental
Arm Description
Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)
Arm Title
Exploratory: AFM13 + AB-101 on CD30-positive PTCL
Arm Type
Experimental
Arm Description
AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)
Intervention Type
Drug
Intervention Name(s)
AFM13
Intervention Description
anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion
Intervention Type
Drug
Intervention Name(s)
AB-101
Intervention Description
NK cell therapy, intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lymphodepleting chemotherapy, intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lymphodepleting chemotherapy, intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Intervention Description
Immune cytokine, subcutaneously
Primary Outcome Measure Information:
Title
Objective Response Rate by Independent Radiology Committee
Description
ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Duration of Response by Investigator and Independent Radiology Committee
Description
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
Time Frame
Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)
Title
Complete response rate (CRR) by Investigator and Independent Radiology Committee
Description
Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.
Time Frame
Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)
Title
ORR by Investigator based on PET-CT as assessed by the Lugano classification
Description
ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification
Time Frame
Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)
Title
Incidence of subjects receiving subsequent transplant
Description
The incidence of subjects receiving subsequent transplant will be assessed and summarized by percentage rates and 95% Confidence Intervals
Time Frame
Throughout study completion (estimated up to 24 months)
Title
Incidence of TEAEs and SAEs
Description
Frequency of subjects with study-drug related treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
From the time of first protocol-specific intervention until 30 days after the last administration
Title
Immunogenicity assessment of AFM13 in combination with AB-101
Description
Frequency of subjects developing anti-drug antibodies (ADAs) against AFM13 or AB-101
Time Frame
During treatment cycles (estimated up 6 months)
Title
Progression-free survival (PFS) by Independent Radiology Committee
Description
Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until PD/OS.
Time Frame
Throughout study completion (estimated up to 24 months)
Title
Overall survival (OS)
Description
Overall survival rate
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes: PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative) Subjects with R/R classical HL must have received at least two lines of therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor. Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin. Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment. Ability to understand and sign the ICF Exclusion Criteria: Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid) Previous treatment with AFM13 or CBNK cells History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents Treatment with any therapeutic mAb or immunosuppressive medications Known active Hepatitis B or C defined per protocol Active HIV Infection History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Affimed GmbH
Phone
004962216743
Ext
60
Email
trials@affimed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karenza Alexis, MD
Organizational Affiliation
Affimed Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Mei, MD
Email
mamei@coh.org

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL

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