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A Phase I Study of JNJ-95804306 for Relapsed or Refractory Hematologic Malignancies
THE PURPOSE OF THIS STUDY IS TO HELP RESEARCHERS UNDERSTAND WHETHER JNJ-95804306 IS SAFE AND EFFECTIVE FOR TREATING PEOPLE WITH ACUTE MYELOID LEUKEMIA (AML), MYELODYSPLASTIC NEOPLASMS (MDS, ALSO KNOWN AS MYELODYSPLASTIC SYNDROME), CHRONIC LYMPHOCYTIC LEUKEMIA (CLL), OR SMALL LYMPHOCYTIC LYMPHOMA (SLL).
THE STUDY AIMS TO DETERMINE A DOSE—THE AMOUNT OF MEDICATION TAKEN AT ONE TIME—OF JNJ-95804306 THAT CAN SAFELY AND EFFECTIVELY TREAT AML, MDS, CLL, AND SLL. IT WILL ALSO ASSESS THE SIDE EFFECTS OF JNJ-95804306, INCLUDING UNEXPECTED OR UNWANTED REACTIONS.
ANOTHER OBJECTIVE IS TO DETERMINE HOW LONG JNJ-95804306 REMAINS IN THE BODY AND HOW THE BODY RESPONDS TO THE MEDICATION. PARTICIPANTS MAY ALSO BE ASKED TO TAKE PART IN A FOOD-EFFECT OR DRUG-INTERACTION COHORT.
EU TRIAL NUMBER: 2026-525234-39
Technical Summary
- PHASE I, FIRST-IN-HUMAN, DOSE-ESCALATION STUDY OF JNJ-95804306 IN RELAPSED OR REFRACTORY HEMATOLOGIC MALIGNANCIES
- Code EudraCT: 2026-525234-39
- Protocol number: 95804306EDI1001
- Promoter: Janssen Cilag SA
- Molecule/Drug: JNJ-95804306
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