MMY1002
Multiple myeloma
A Phase 1b study of JNJ-79635322 (BCMA × GPRC5D × CD3 trispecific
Ab) in combination with daratumumab or pomalidomide for MM
Phase
b
Compound
JNJ-79635322 (BCMA × GPRC5D × CD3 trispecific Ab) + daratumumab (anti-CD38 mAb) or pomalidomide or daratumumab + lenalidomide
NCT identifier
NCT06768489
Enrollment
N=~140
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:
- Initial diagnosis of MM according to IMWG diagnostic criteria
- Meet treatment regimen-specific requirements as follows:
- Treatment regimens A and C (JNJ-79635322 + daratumumab):
- Treatment regimen A1: 1–3 prior LOT including a PI and an IMiD
- Treatment regimens A2 and C: NDMM naive to MM (or other related plasma cell neoplasm)–directed treatments
- Treatment regimen B (JNJ-79635322 + pomalidomide):
≥1 prior LOT including a PI and lenalidomide (refractory); or ≥2 prior LOT including a PI and lenalidomide - Treatment regimens D and E (JNJ-79635322 + daratumumab + lenalidomide): NDMM naive to MM (or other related plasma cell neoplasm)–directed treatments
- Treatment regimens A and C (JNJ-79635322 + daratumumab):
- Measurable disease at screening
- ECOG PS 0–2
- No prior allogeneic transplant within 6 months or autologous transplant within 12 weeks of first dose of study treatment
- No prior treatment with CD3-redirecting therapy
Study
design
Primary outcomes:
Part 1
- DLTs
Parts 1 and 2
- AEs by severity
- Clinically significant laboratory abnormalities
Secondary outcomes*:
- ORR
- DOR
- TTR
- Serum concentration of JNJ-79635322 and daratumumab
- ADAs
- Cmax
- Tmax
*Not a complete list of secondary endpoints.
Ab, antibody; ADA, antidrug antibody; AE, adverse event; BCMA, B-cell maturation antigen; CD, cluster of differentiation; Cmax, maximum serum concentration; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GPRC5D, G protein–coupled receptor class C group 5 member D; IMiD, immunomodulatory drug; IMWG, International Myeloma Working Group; LOT, line of therapy; MM, multiple myeloma; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; PI, proteasome inhibitor; PO, orally; SC, subcutaneous; Tmax, time to reach Cmax; TTR, time to response.