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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Treatments: Biological: JNJ-90014496

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05421663

2023-506267-33-00 (Registry Identifier)

90014496LYM1001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

JNJ-90014496

Experimental group

Description:

Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.

Treatment:

Biological: JNJ-90014496