A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-80948543: JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780: JNJ-75348780 will be administered as SC injection.
Study summary
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Eligibility
Primary outcome measure(s)
- Number of Participants with Dose-limiting Toxicity (DLT) — Up to 1 year and 10 months
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia). - Number of Participants with Adverse Events (AEs) — Up to 1 year and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Concord Hospital | Concord | Australia | |
| St Vincents Hospital Melbourne | Fitzroy | Australia | |
| Macquarie University Hospital | North Ryde | Australia | |
| Hosp Univ Vall D Hebron | Barcelona | Spain | |
| Hosp. Clinic de Barcelona | Barcelona | Spain | |
| Inst. Cat. Doncologia-H Duran I Reynals | L'Hospitalet de Llobregat | Spain | |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | Spain | |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | |
| China Medical University Hospital | Taichung | Taiwan | |
| National Taiwan University Hospital | Taipei | Taiwan | |
| University Hospitals Of Leicester Nhs Trust | Leicester | United Kingdom |
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06660563 on ClinicalTrials.gov ↗ ← All trials in Spain