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New hope for tough blood cancers? early trial launches

NCT ID NCT07572006

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-stage trial is testing an experimental drug called JNJ-95804306 in people with blood cancers like leukemia that have come back or not responded to standard treatments. The study has two parts: first, finding a safe dose, and then checking if the drug shrinks tumors when used alone or with standard care. About 280 participants will take part across multiple sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JNJ-95804306
What this could lead to
If successful, this could point toward a new treatment option for people with blood cancers that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial, so the drug may not be effective or may cause serious side effects. It is also small and focused on safety, not proof of benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia B-cell chronic lymphocytic leukemia hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus N, DK-8200, Denmark

  • CHU Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • Clinica Univ. de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hosp Univ Fund Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Indiana Blood & Marrow Transplantation

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • MD Anderson Cancer Center - University of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    Piscataway, New Jersey, 08854, United States

  • Sarah Cannon Cancer Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Start Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Christie Nhs Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UZ Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

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