RecruitingPhase 1NCT07572006

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

A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies


Sponsor

Janssen Research & Development, LLC

Enrollment

360 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AML SoC, a drug called CLL/SLL SoC, and others for people with hematologic neoplasms. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-95804306

JNJ-95804306 will be administered orally.

DRUGAML SoC

AML SoC will be administered subcutaneously/intravenously.

DRUGCLL/SLL SoC

CLL/SLL SoC will be administered orally/ intravenously.


Locations(8)

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

Peter MacCallum Cancer Centre

Melbourne, Australia

UZ Antwerpen

Edegem, Belgium

The Christie Nhs Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07572006


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