A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Treatments: Drug: JNJ-90009530

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05784441

90009530LYM1001

2023-506259-97-00 (Registry Identifier)

Details and patient eligibility

About

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:

• can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
• will JNJ-90009530 help patients achieve a response and for how long?

Full description

This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

This trial will employ the Bayesian optimal interval (BOIN) design to determine the recommended Phase 2 dose (RP2D).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent

• All participants must have relapsed or refractory disease for each histologic subtype

  • Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 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). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
  • 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

• Tumor must be cluster of differentiation (CD) 20 positive

• Measurable disease as defined by Lugano 2014 classification

• Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

Key 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
• Active central nervous system (CNS) involvement by malignancy
• 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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20 participants in 1 patient group

JNJ-90009530

Experimental group

Treatment:

Drug: JNJ-90009530