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

PHASE1RECRUITING

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?.

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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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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)

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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

$Image related to Relapsed or Refractory B Cell Non-Hodgkin Lymphoma$

Condition: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
DRUG: JNJ-90009530
Westmead, Not Specified, Australia and more
Sponsor: Janssen Research & Development, LLC

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Not Specified	DRUG: JNJ-90009530 JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20

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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You may be eligible to participate in this trial based on your search.Apply for study

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References

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