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A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
Sponsor: Janssen Research & Development, LLC
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).
Official title: A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2026-05-13
Completion Date
2032-09-24
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
JNJ-95804306
JNJ-95804306 will be administered orally.
AML SoC
AML SoC will be administered subcutaneously/intravenously.
CLL/SLL SoC
CLL/SLL SoC will be administered orally/ intravenously.
Locations (3)
Indiana Blood & Marrow Transplantation
Indianapolis, Indiana, United States
Start Midwest
Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, United States