A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Purpose
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?
Condition
- Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JNJ-90009530 |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky
Lexington, Kentucky 40506
Lexington, Kentucky 40506
More Details
- NCT ID
- NCT05784441
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC
Detailed 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).