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

Recruiting now · Phase 1

Conditions studied: Hematologic Neoplasms

In brief

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).

Key facts

Study ID

NCT07572006

Run by

Janssen Research & Development, LLC

People needed

360

Starts

2026-05-13

Expected to finish

2032-09-24

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Arm A:
• Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
• Body weight greater than or equal to (>=) 40 kilograms (kg)
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2
• For Arm B:
• All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:
• a. Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease
• Body weight >= 40 kg
• ECOG performance status of 0 to 2
• Must sign an Informed consent form (ICF)
• For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy

You may not qualify if…

• For Arm A:
• Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
• For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS
• For Arm B:
• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
• Developed Richter's transformation or prolymphocytic leukemia
• Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)

Where it is running

• Indiana Blood & Marrow Transplantation — Indianapolis, Indiana, United States (enrolling)
• Start Midwest — Grand Rapids, Michigan, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — Piscataway, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Sarah Cannon Cancer Institute — Nashville, Tennessee, United States (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Australia (enrolling)
• UZ Antwerpen — Edegem, Belgium (enrolling)
• The Christie Nhs Foundation Trust — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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