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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

Study Description
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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?

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Drug: JNJ-90009530 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2023
Estimated Primary Completion Date : April 1, 2027
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: JNJ-90009530 Drug: JNJ-90009530
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Other Name: C-CAR066


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05784441


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, Iowa
University of Iowa Hospital Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
United States, New Jersey
Rutgers University Recruiting
New Brunswick, New Jersey, United States, 08901
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Australia
Royal Prince Alfred Hospital Recruiting
Camperdown, Australia, 2050
Monash Medical Centre Recruiting
Clayton, Australia, 3168
Royal Brisbane and Women's Hospital Recruiting
Herston, Australia, 4029
Westmead Hospital Recruiting
Westmead, Australia, 2145
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9112001
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5266202
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05784441    
Other Study ID Numbers: 90009530LYM1001
2023-506259-97-00 ( Registry Identifier: EUCT number )
First Posted: March 24, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases