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A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Primary Purpose

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JNJ-90009530
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

Eligibility Criteria

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

Key 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 cluster of differentiation (CD) 20 positive by immunohistochemistry Have relapsed or refractory disease after >= 2 lines of standard therapy and relapsed within 12 months of last therapy Measurable disease as defined by Lugano 2014 classification Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 Key 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 Active central nervous system (CNS) involvement by malignancy Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    JNJ-90009530

    Arm Description

    Outcomes

    Primary Outcome Measures

    Calculate the incidence of adverse events
    The safety and tolerability will be measured by recording the incidence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0
    Determine Recommended Phase 2 dose (RP2D)
    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities

    Secondary Outcome Measures

    Determine the overall response rate (ORR)
    Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014
    Determine the time to response (TTR)
    Record the number of days from the date of JNJ-90009530 infusion to a CR or PR
    Determine the duration of response (DOR)
    Record the number of days from the date of the first CR or PR to relapse or death.
    Measure the amount of JNJ-90009530 in blood over time
    Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).

    Full Information

    First Posted
    March 3, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784441
    Brief Title
    A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
    Official Title
    A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 25, 2023 (Anticipated)
    Primary Completion Date
    May 21, 2026 (Anticipated)
    Study Completion Date
    November 29, 2026 (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
    Yes

    5. Study Description

    Brief Summary
    The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients. will JNJ-90009530 help patients achieve a response and for how long?
    Detailed Description
    This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). This trial will employ the Bayesian optimal interval (BOIN) design to determine the recommended Phase 2 dose (RP2D).

    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

    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-90009530
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    JNJ-90009530
    Other Intervention Name(s)
    C-CAR066
    Intervention Description
    JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
    Primary Outcome Measure Information:
    Title
    Calculate the incidence of adverse events
    Description
    The safety and tolerability will be measured by recording the incidence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0
    Time Frame
    up to 24 months
    Title
    Determine Recommended Phase 2 dose (RP2D)
    Description
    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities
    Time Frame
    up to 24 months
    Secondary Outcome Measure Information:
    Title
    Determine the overall response rate (ORR)
    Description
    Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014
    Time Frame
    up to 24 months
    Title
    Determine the time to response (TTR)
    Description
    Record the number of days from the date of JNJ-90009530 infusion to a CR or PR
    Time Frame
    up to 24 months
    Title
    Determine the duration of response (DOR)
    Description
    Record the number of days from the date of the first CR or PR to relapse or death.
    Time Frame
    up to 24 months
    Title
    Measure the amount of JNJ-90009530 in blood over time
    Description
    Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).
    Time Frame
    up to 24 months
    Other Pre-specified Outcome Measures:
    Title
    Evaluate progression-free survival
    Description
    Progression-free survival is defined as time from the date of JNJ-90009530 infusion to the date of first documented disease progression or death, whichever occurs first
    Time Frame
    up to 24 months
    Title
    Evaluate overall survival
    Description
    Measure overall survival by days as time from the date of JNJ-90009530 infusion to the date of death
    Time Frame
    up to 24 months
    Title
    Investigate the pharmacodynamic biomarkers
    Description
    Measure and quantify biomarkers in serum and whole blood samples.
    Time Frame
    up to 24 months
    Title
    Evaluate the concentration of anti-drug antibodies (ADA)
    Description
    Determine immunogenicity by measuring the number of anti-drug antibodies in blood over time after administration of JNJ-90009530
    Time Frame
    up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key 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 cluster of differentiation (CD) 20 positive by immunohistochemistry Have relapsed or refractory disease after >= 2 lines of standard therapy and relapsed within 12 months of last therapy Measurable disease as defined by Lugano 2014 classification Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 Key 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 Active central nervous system (CNS) involvement by malignancy 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
    Phone
    844-434-4210
    Email
    Participate-In-This-Study@its.jnj.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Research & Development, LLC Clinical Trial
    Organizational Affiliation
    Janssen Research & Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
    IPD Sharing URL
    https://www.janssen.com/clinical-trials/transparency

    Learn more about this trial

    A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

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