Clinical Trial

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Recruiting Phase 1
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Summary
The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).
Protocol Amendment History 4 changes
notable Enrollment increased: 280 -> 360 participants 2026-07-23
notable Trial sites expanded: 3 -> 8 locations 2026-07-23
critical Recruitment opened 2026-05-27
notable Trial sites expanded: 0 -> 3 locations 2026-05-27
Trial Details
NCT Number NCT07572006
Lead Sponsor Janssen Research & Development, LLC
Conditions Hematologic Neoplasms
Enrollment 360 participants
Start Date 2026-05-13
Primary Completion 2029-05-18 (estimated)
Study Completion 2032-09-24 (estimated)
Updated on ClinicalTrials.gov 2026-07-22