A study of JNJ-90014496 in relapsed or refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL)

Phase 1

Conditions: on-Hodgkin lymphoid malignancies
Cancer

Registration Number: ISRCTN15038320

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 92

Inclusion Criteria

1. Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
2. 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
3. Tumor must be cluster of differentiation (CD) 20 positive
4. Measurable disease as defined by Lugano 2014 classification
5. Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

Exclusion Criteria

1. Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
2. Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
3. Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
4. Uncontrolled active infections
5. History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
6. 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
7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder
8. Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
9. Active central nervous system (CNS) involvement by malignancy
10. Current active liver or biliary disease (except for Gilbert’s syndrome or asymptomatic gallstones)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of AEs and abnormal laboratory results, including dose limiting toxicities (DLTs) for up to 24 months

Secondary Outcome Measures

Name	Time	Method
1. Overall Response (OR), which includes Partial Response (PR) and Complete Response (CR), for up to 24 months<br>2. Time to response (TTR), defined as the time from the date of JNJ-90014496 infusion to the first documented CR or PR for up to 24 months<br>3. Duration of response (DOR), defined as the time from the first documented CR or PR to relapse or death (whichever occurs first) for up to 24 months<br>4. Amount of JNJ-90014496 in blood over time for up to 24 months