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

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

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 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?

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: JNJ-90009530

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: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Royal Prince Alfred Hospital
  • Clayton, Australia, 3168
    • Monash Medical Centre
  • Heidelberg, Australia, 3084
    • Austin Hospital
  • Herston, Australia, 4029
    • Royal Brisbane and Women's Hospital
  • Westmead, Australia, 2145
    • Westmead Hospital
• Israel
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center
  • Ramat Gan, Israel, 5266202
    • Sheba Medical Center
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College London Hospitals
• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-90009530	Drug: JNJ-90009530; JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20; Other Names: C-CAR066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 months
Calculate the Occurence of Adverse Events	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	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the duration of response (DOR)	Record the number of days from the date of the first CR or PR to relapse or death.	up to 24 months
Determine the time to response (TTR)	Record the number of days from the date of JNJ-90009530 infusion to a CR or PR	up to 24 months
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).	up to 24 months
Determine the Overall Response (OR)	Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014	up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate progression-free survival	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	up to 24 months
Evaluate overall survival	Measure overall survival by days as time from the date of JNJ-90009530 infusion to the date of death	up to 24 months
Investigate the pharmacodynamic biomarkers	Measure and quantify biomarkers in serum and whole blood samples.	up to 24 months
Evaluate the concentration of anti-drug antibodies (ADA)	Determine immunogenicity by measuring the number of anti-drug antibodies in blood over time after administration of JNJ-90009530	up to 24 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Collaborators: Mayo Clinic
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 3, 2040

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Lymphoma, B-Cell
• Other Study ID Numbers: 90009530LYM1001 (Other Identifier: Janssen Research & Development, LLC); 2023-506259-97-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No