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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


Description

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?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).

Trial Eligibility

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 Info

Organization

Janssen Research & Development, LLC


Primary Outcome

Calculate the Occurence of Adverse Events


Outcome Timeframe up to 24 months

NCTID NCT05784441

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-11-06

Completion Date 2027-04-01

Enrollment Target 20

Interventions

DRUG JNJ-90009530

Locations Recruiting

University of Iowa Hospital

United States, Iowa, Iowa City


University of Kentucky

United States, Kentucky, Lexington


Mayo Clinic Rochester

United States, Minnesota, Rochester


Rutgers University

United States, New Jersey, New Brunswick


University Hospitals Cleveland Medical Center

United States, Ohio, Cleveland


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