A Phase 1b Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-Cell Non-Hodgkin Lymphoma

Description

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).

Trial Eligibility

Inclusion Criteria: * Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent * Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive * Must meet the following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have had \>= 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); Relapsed or refractory follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody * Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL * Measurable disease as defined by Lugano 2014 classification * Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort Exclusion Criteria: * Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma * Any prior solid organ or allogeneic stem cell transplantation * 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, 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 * Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

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