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

Janssen (J&J Innovative Medicine) logo

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

104 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

Trial contacts and locations

17

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Central trial contact

Study Contact, M.D.

Data sourced from clinicaltrials.gov

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