Overview
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?
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).
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)