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A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
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?.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-11-06
Primary completion: 2027-04-01
Study completion finish: 2027-05-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05784441
Intervention or treatment
DRUG: JNJ-90009530
Conditions
- • Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Westmead, Not Specified, Australia
Royal Prince Alfred Hospital
Camperdown, Not Specified, Australia
Monash Medical Centre
Clayton, Not Specified, Australia
Austin Hospital
Heidelberg, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: JNJ-90009530
| DRUG: JNJ-90009530
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 |
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 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 |
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 |
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 |
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 |
Frequently Asked Questions
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