95566692LYM1001
B-cell malignancies
A Phase 1, first-in-human study of JNJ-95566692 (CD79b × CD20 × CD3 trispecific Ab) in B-cell non-Hodgkin lymphoid malignancies
Phase
Compound
JNJ-95566692 (CD79b × CD20 × CD3 trispecific Ab) ± JNJ-87801493 (CD20 × CD28 bispecific Ab)
NCT identifier
NCT07308132
Enrollment
N=~130
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Relapsed or refractory B-cell non-Hodgkin lymphoid malignancies
- ≥2 prior lines of standard therapy, or ≥1 prior line of therapy but not eligible or without access to standard second-line therapies
- Measurable disease as defined by Lugano criteria
- ECOG PS of 0 or 1
Study
design
Primary outcomes†:
- Part 1 and 2: Safety
- Part 1: DLTs
Secondary outcomes†:
- Serum concentrations
- AUCtau
- Cmax
- t1/2
- Tmax
- Part 2: overall response, CR, DOR, TTR, PFS
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
AUCtau, area under the curve during a dosing interval; Cmax, maximum serum concentration; CR, complete response; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; PFS, progression-free survival; SC, subcutaneous; t1/2, half-life; Tmax, time to reach Cmax; TTR, time to response.