A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
- Conditions
- Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT05784441
- Lead Sponsor
- Janssen Research & Development, LLC
- 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 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JNJ-90009530 JNJ-90009530 -
- Primary Outcome Measures
Name Time Method Calculate the Occurence of Adverse Events 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) 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
Name Time Method Determine the Overall Response (OR) 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) 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) 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 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).
Trial Locations
- Locations (15)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Iowa Hospital
🇺🇸Iowa City, Iowa, United States
Monash Medical Centre
🇦🇺Clayton, Australia
Austin Hospital
🇦🇺Heidelberg, Australia
Westmead Hospital
🇦🇺Westmead, Australia
Hadassah Medical Center
🇮🇱Jerusalem, Israel
University College London Hospitals
🇬🇧London, United Kingdom
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Australia
Sheba Medical Center
🇮🇱Ramat Gan, Israel
University of Kentucky
🇺🇸Lexington, Kentucky, United States