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A Study of JNJ-95804306 for Blood Cancers

This study is testing a new oral medication called JNJ-95804306 for people with certain types of blood cancers (hematologic malignancies) that have come back or haven't responded to previous treatments. These include acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) that are moderate to very high-risk. The main goals are to find a safe and tolerable dose of JNJ-95804306, and to see how well it works, both on its own and when given with standard treatments. The study plans to enroll 360 participants.

Study design
This is an interventional study with an enrollment of 360 participants. It aims to assess the safety and anti-tumor activity of JNJ-95804306.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to 6 years and 5 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07572006

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~360 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:JNJ-95804306AML SoCCLL/SLL SoC

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured over Up to 28 days after first full dose of study drug
+1 more outcome measured

Conditions

Hematologic Neoplasms

Explore related trials

Acute Myeloid LeukemiaChronic Lymphocytic LeukemiaHematologic NeoplasmMyelodysplastic SyndromeSmall Lymphocytic Lymphoma

Where it's being run

15 sites across 12 states
France3
Spain2
Indiana1
Michigan1
New Jersey1
New York1
Tennessee1
Texas1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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:
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

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
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 trial measures

  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)Up to 28 days after first full dose of study drug

    DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (\<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.

  • Number of Participants with Adverse Events (AEs) by SeverityUp to 6 years 5 months

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.