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

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling

Phase 1

Conditions

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Treatments

Biological: JNJ-90014496

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05421663

2023-506267-33-00 (Registry Identifier)

2023-506267-33 (EudraCT Number)

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 relapsed or refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL).

Enrollment

104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular lymphoma
Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
Must have relapsed or refractory disease with the following indications for each histologic subtype: Mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy, or >= 1 line of systemic therapy for participants who are ineligible for autologous stem cell transplant; 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
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
Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)