Non Hodgkin Lymphoma Clinical Trial

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

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?

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Full 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).

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT05784441

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 13 Locations for this study

See Locations Near You

University of Iowa Hospital
Iowa City Iowa, 52242, United States
University of Kentucky
Lexington Kentucky, 40506, United States
Rutgers University
New Brunswick New Jersey, 08901, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Monash Medical Centre
Clayton , 3168, Australia
Austin Hospital
Heidelberg , 3084, Australia
Royal Brisbane and Women's Hospital
Herston , 4029, Australia
Westmead Hospital
Westmead , 2145, Australia
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 52662, Israel

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT05784441

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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