The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05784441
Recruitment Status : Recruiting
First Posted : March 24, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 3, 2023
First Posted Date  ICMJE March 24, 2023
Last Update Posted Date April 25, 2024
Actual Study Start Date  ICMJE November 6, 2023
Estimated Primary Completion Date April 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2023)
  • Calculate the Occurence of Adverse Events [ Time Frame: up to 24 months ]
    The safety and tolerability will be measured by recording the occurence 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) [ Time Frame: up to 24 months ]
    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2023)
  • Calculate the incidence of adverse events [ Time Frame: up to 24 months ]
    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 V5.0
  • Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) [ Time Frame: up to 24 months ]
    Employ a Bayesian optimal interval (BOIN) design, with a dosing finding Run-In, to find the MTD and/or determine the RP2D with review of the number of dose-limiting toxicities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2023)
  • Determine the Overall Response (OR) [ Time Frame: up to 24 months ]
    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) [ Time Frame: up to 24 months ]
    Record the number of days from the date of JNJ-90009530 infusion to a CR or PR
  • Determine the duration of response (DOR) [ Time Frame: up to 24 months ]
    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 [ Time Frame: up to 24 months ]
    Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2023)
  • Determine the overall response rate (ORR) [ Time Frame: up to 24 months ]
    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) [ Time Frame: up to 24 months ]
    Record the number of days from the date of C-CAR066 infusion to a CR or PR
  • Determine the duration of response (DOR) [ Time Frame: up to 24 months ]
    Record the number of days from the date of the first CR or PR to relapse or death.
  • Measure the amount of C-CAR066 in blood over time [ Time Frame: up to 24 months ]
    Review pharmacokinetics (PK) of C-CAR066 by measuring the CAR copy number over time by Quantitative polymerase chain reaction (qPCR).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 23, 2023)
  • Evaluate progression-free survival [ Time Frame: up to 24 months ]
    Progression-free survival is defined as time from the date of C-CAR066 infusion to the date of first documented disease progression or death, whichever occurs first
  • Evaluate overall survival [ Time Frame: up to 24 months ]
    Measure overall survival by days as time from the date of C-CAR066 infusion to the date of death
  • Investigate the pharmacodynamic biomarkers [ Time Frame: up to 24 months ]
    Measure serum and whole blood samples to determine cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ) and concentration of CD20 positive B cells
  • Evaluate the concentration pf anti-drug antibodies (ADA) [ Time Frame: up to 24 months ]
    Determine immunogenicity by measuring the number of anti-drug antibodies in blood over time after administration of C-CAR066
  • Measure blood samples to determine concentration of cytokines over time. [ Time Frame: up to 24 months ]
  • Measure blood samples to determine the concentration of CD20 positive B cells over time. [ Time Frame: up to 24 months ]
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Intervention  ICMJE Drug: JNJ-90009530
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Other Name: C-CAR066
Study Arms  ICMJE Experimental: JNJ-90009530
Intervention: Drug: JNJ-90009530
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2023)		 92
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2023)		 15
Estimated Study Completion Date  ICMJE May 31, 2027
Estimated Primary Completion Date April 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  • Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent

  • All participants must have relapsed or refractory disease for each histologic subtype

    • Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
    • Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
  • Tumor must be cluster of differentiation (CD) 20 positive
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Australia,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05784441
Other Study ID Numbers  ICMJE 90009530LYM1001
2023-506259-97-00 ( Registry Identifier: EUCT number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party AbelZeta, Inc.
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE AbelZeta, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP