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RECRUITING
NCT07572006
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

JNJ-95804306

JNJ-95804306 will be administered orally.

DRUG

AML SoC

AML SoC will be administered subcutaneously/intravenously.

DRUG

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