A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-87801493: JNJ-87801493 will be administered subcutaneously.
JNJ-80948543: JNJ-80948543 will be administered subcutaneously.
JNJ-75348780: JNJ-75348780 will be administered subcutaneously.
Study summary
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) \[Part A: Dose Escalation\] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs \[Part B: Dose Expansion\].
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) — Up to 2 years 7 months
Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity - Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity — Up to 2 years 7 months
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events \[ICANS\]).
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Austin Hospital | Heidelberg | Australia | |
| The Alfred Hospital | Melbourne | Australia | |
| Linear Clinical Research Ltd | Nedlands | Australia | |
| Scientia Clinical Research | Randwick | Australia | |
| Rigshospitalet | Copenhagen | Denmark | |
| Odense University Hospital | Odense | Denmark | |
| Hadassah Medical Center | Jerusalem | Israel | |
| Sourasky (Ichilov) Medical Center | Tel Aviv | Israel | |
| Hosp Univ Vall D Hebron | Barcelona | Spain | |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | |
| Clinica Univ. de Navarra | Pamplona | Spain | |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain |
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 NCT06139406 on ClinicalTrials.gov ↗ ← All trials in Spain