95804306EDI1001
Myeloid malignancies
A Phase 1, nonrandomized, first-in-human, open-label study of JNJ-95804306 in participants with relapsed or refractory AML, high-risk MDS, or CLL/SLL
Phase
Compound
JNJ-95804306 ± SOC
NCT identifier
NCT07572006
Enrollment
N=~280
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*:
- Arm A: Relapsed or refractory AML or high-risk MDS
- Arm A: No acute promyelocytic leukemia or known active CNS involvement of AML/MDS
- Arm B: Relapsed or refractory CLL/SLL that requires treatment with no other approved therapy available that would be more appropriate
- Arm B: ≥2 prior lines of therapy
- Arm B: ≥1 prior line of therapy but are not eligible or do not have access to standard second line therapies
- Arm B: No known active CNS or leptomeningeal involvement of CLL/SLL
Study
design
Primary outcomes:
- Part 1: DLTs
- Parts 1 and 2: AEs by severity
Secondary outcomes‖:
- PK
- CR
- OR in MDS, CLL, and SLL
- DOR
- TTR
*Not a complete list of inclusion and exclusion criteria. †Relapsed or refractory AML or high-risk MDS. ‡Relapsed or refractory CLL/SLL. §AML or CLL/SLL SOC will not be administered for US sites. ‖Not a complete list of outcomes.
AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; 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 syndrome; OR, overall response; PK, pharmacokinetics; SLL, small lymphocytic lymphoma; SOC, standard of care; TTR, time to response.