89853413AML1001
Myeloid malignancies
A Phase 1, first-in-human, dose escalation study of JNJ-89853413
(CD33 × Vδ2 bispecific Ab) for relapsed or refractory AML or MDS
Phase
Compound
JNJ-89853413 (CD33 × Vδ2 bispecific Ab)
NCT identifier
NCT06618001
Enrollment
N=~115
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*:
- Diagnosed AML or high-risk MDS
- ECOG PS 0–2
- Adequate renal function
- No medical history of clinically significant pulmonary compromise
- No active CNS involvement
Study
design
Primary outcomes:
- DLTs (Part 1)
- AEs
Secondary outcomes:
- Serum concentration of JNJ-89853413
- ADAs
- PK
- Overall response in MDS
- CR
- TTR
- DOR
- Transfusion independence
*Not a complete list of inclusion and exclusion criteria.
Ab, antibody; ADA, antidrug antibody; AE, adverse event; AML, acute myeloid leukemia; CD, cluster of differentiation; CNS, central nervous system; CR, complete response; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; MDS, myelodysplastic neoplasms; PK, pharmacokinetics; TTR, time to response; Vδ2, variable delta 2.