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NCT07572006From ClinicalTrials.govRecruiting

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

  • Hematologic Neoplasms

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
360
Started
13 May 2026
Main results due
18 May 2029
Study sites
16
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion criteria:

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

Exclusion criteria:

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)

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(16)

  • Indiana Blood & Marrow Transplantation

    Indianapolis, Indiana, United States

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, United States

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    Piscataway, New Jersey, United States

    Recruiting

  • NYU Langone Health

    New York, New York, United States

    Recruiting

  • Sarah Cannon Cancer Institute

    Nashville, Tennessee, United States

    Recruiting

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, United States

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

    Recruiting

  • UZ Antwerpen

    Edegem, Belgium

    Recruiting

  • Aarhus University Hospital

    Aarhus N, Denmark

    Recruiting

  • Institut Paoli Calmettes

    Marseille, France

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, France

    Recruiting

  • Institut Claudius Regaud

    Toulouse, France

    Recruiting

  • CHRU Tours Hopital Bretonneau

    Tours, France

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, Spain

    Recruiting

  • The Christie Nhs Foundation Trust

    Manchester, United Kingdom

    Recruiting

Showing 16 of 16 sites. 16 of the 16 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07572006. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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