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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
360
Start Date
2026-05-13
Completion Date
2032-09-24
Last Updated
2026-08-28
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 (15)
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
NYU Langone Health
New York, New York, United States
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Australia
UZ Antwerpen
Edegem, Belgium
Aarhus University Hospital
Aarhus N, Denmark
Institut Paoli Calmettes
Marseille, France
CHU Lyon Sud
Pierre-Bénite, France
Institut Claudius Regaud
Toulouse, France
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
The Christie Nhs Foundation Trust
Manchester, United Kingdom