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A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Clinicaltrials.gov:
EU CTIS:
#2023-506267-33-00
Other:
#90014496LYM1001
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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 in Phase 1b: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma (FL) 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 FL 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 consistent with lymphoma after 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL; Phase 2 participants must have following: A diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy including an anthracycline containing chemotherapy regimen and an anti-CD20 monoclonal antibody; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; Cohort specific requirements:

Cohort A (CAR-T Naïve): participants who have previously not received CAR-T cell therapy for the treatment of lymphoma.

Cohort B (CAR-T Exposed): participants who have relapsed disease and prior exposure to CAR-T cell therapy for the treatment of lymphoma.

- Measurable disease as defined by Lugano 2014 classification

- Eastern cooperative oncology group (ECOG) performance status of 0 to 2

Exclusion Criteria:

- History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)

- 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 apheresis

- 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)

- Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection

- Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and Burkitt-like lymphoma or Richter's transformation, Lymphomatoid granulomatosis, Plasmablastic lymphoma

- Any prior solid organ or allogeneic stem cell transplantation

- Autologous stem cell transplant within 12 weeks of apheresis; CAR-T exposed only: Prior CAR-T cell therapy within 12 weeks of apheresis

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
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