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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

280

Start Date

2026-05-13

Completion Date

2032-09-24

Last Updated

2026-06-05

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 (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