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A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Primary Purpose

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JNJ-90014496
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma focused on measuring CD19/CD20-directed CAR-T Cells

Eligibility Criteria

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

Inclusion Criteria

  • ≥ 18 years of age, at the time of signing informed consent
  • Diagnosis of aggressive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:

    1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
    2. Primary mediastinal large B-cell lymphoma (PMBCL)
    3. Transformed follicular lymphoma (tFL)
    4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
    5. High-grade B-cell lymphoma, NOS
    6. Follicular lymphoma grade 3B (FL3B)
  • Histologically confirmed CD19 or CD20 positive disease by immunohistochemistry test result and corresponding pathology report
  • Relapsed or refractory disease after ≥ 2 lines of standard therapy and having relapsed within 12 months of receipt of the most recent anti-lymphoma treatment

    a) For patients with DLBCL, PMBCL, high-grade B-cell lymphomas, tFL and FL grade 3B, patients must have been treated with a line of therapy with an anthracycline and a line of therapy with an anti-CD20 targeted agent

  • Measurable disease per the Lugano 2014 Classification, having at least one measurable lesion defined as:

    1. Nodal lesion with longest diameter ≥ 1.5 cm
    2. Extranodal lesion with longest diameter ≥ 1.0 cm
  • ECOG performance status of either 0 or 1 at screening
  • Adequate bone marrow, liver, renal and cardiopulmonary function

Exclusion Criteria

  • HHV8-positive DLBCL
  • Prior allogeneic HSCT
  • Autologous stem cell transplant within 12 weeks of CAR T cell infusion
  • Inadequate wash-out time for previous anti-tumor treatments prior to C-CAR039 infusion
  • Received a live vaccine within 4 weeks of leukapheresis
  • Uncontrolled active HIV, HBC, or HCV infection
  • History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated DVT is allowed)
  • History of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease
  • Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
  • Active CNS involvement by malignancy
  • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
  • Previous (within 5 years) or concurrent malignancy except for basal cell or squamous cell carcinoma or In situ carcinoma of the cervix or breast in complete remission
  • Pregnant or lactating women
  • Allergies to concomitant drugs used in this study or C-CAR039 cell product
  • Other co-morbid condition or disease that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial

Sites / Locations

  • City of HopeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JNJ-90014496

Arm Description

Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs) [Safety and Tolerability]
Incidence of any AEs, including dose limiting toxicities (DLTs).
Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)
Based on the assessment of DLTs rates and overall safety profile.

Secondary Outcome Measures

Overall Response Rate (ORR)
Complete response (CR) rate and partial response (PR) rate.
Time to Response (TTR)
The time from the date of JNJ-90014496 infusion to the first documented CR or PR.
Duration of Response (DOR)
The time from the first documented CR or PR to relapse or death, whichever occurs first.
Pharmacokinetic Evaluation of JNJ-90014496
JNJ-90014496 blood levels will be reported.

Full Information

First Posted
June 10, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05421663
Brief Title
A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Official Title
A Phase Ib Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
May 29, 2026 (Anticipated)
Study Completion Date
October 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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

5. Study Description

Brief Summary
This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with relapsed or refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Keywords
CD19/CD20-directed CAR-T Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JNJ-90014496
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.
Intervention Type
Biological
Intervention Name(s)
JNJ-90014496
Intervention Description
JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) - T cell therapy targeting CD19 and CD20.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Description
Incidence of any AEs, including dose limiting toxicities (DLTs).
Time Frame
Up to 24 months
Title
Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)
Description
Based on the assessment of DLTs rates and overall safety profile.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Complete response (CR) rate and partial response (PR) rate.
Time Frame
Up to 24 months
Title
Time to Response (TTR)
Description
The time from the date of JNJ-90014496 infusion to the first documented CR or PR.
Time Frame
Up to 24 months
Title
Duration of Response (DOR)
Description
The time from the first documented CR or PR to relapse or death, whichever occurs first.
Time Frame
Up to 24 months
Title
Pharmacokinetic Evaluation of JNJ-90014496
Description
JNJ-90014496 blood levels will be reported.
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 Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular lymphoma grade 3B Tumor must be histologically confirmed cluster of differentiation (CD)19 or CD20 positive Have relapsed or refractory disease after >= 2 lines of standard therapy, or >= 1 line of standard therapy for participants who are ineligible for autologous stem cell transplant Measurable disease as defined by Lugano 2014 classification Eastern cooperative oncology group (ECOG) performance status of either 0 or 1 Exclusion Criteria Diagnosis of Human herpes virus (HHV) 8-positive diffuse large B Cell lymphoma (DLBCL) Prior allogeneic hematopoietic stem cell transplantation (HSCT) Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion Uncontrolled active infections History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT]) History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact, M.D.
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Baird, M.D.
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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