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New hope for tough blood cancers: experimental drug JNJ-90189892 enters human testing

NCT ID NCT06651229

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-stage trial is testing an experimental drug called JNJ-90189892 in about 155 people with acute myeloid leukemia (AML) or myelodysplastic neoplasms (MDS) that have come back or not responded to treatment. The study has several parts: first, finding a safe dose of JNJ-90189892 alone, then testing it in combination with two other drugs (azacitidine and venetoclax) in both relapsed/refractory and newly diagnosed AML. The main goals are to check safety and find the right dose for future studies.

What this could mean

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

Active substance
JNJ-90189892 (an experimental drug) given alone or with azacitidine and venetoclax
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat AML or MDS.
What could go wrong
This is an early Phase 1 trial, so the main goal is safety, not proof of effectiveness. Many experimental drugs fail at this stage, and side effects may be serious.

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 155 people

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

Started

Mar 2025

Expected to finish

Nov 2028

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: * A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria * Body weight that is greater than or equals to (\>=) 40 kg * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \>=40 milligrams per minute (mL/min) computed with the calculator on the national kidney foundation website * Participants must have laboratory parameters in the required range Exclusion Criteria: * Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation * Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted * All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients * Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892 * Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment * Has known active central nervous system involvement

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

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

Leukemia, myeloid, acute Myelodysplastic neoplasms

How to take part

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

  1. The places running it

    9 sites in 3 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

  • CHRU de Strasbourg - Hopital de Hautepierre

    RECRUITING

    Strasbourg, 67200, France

  • Clinica Univ. de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Concord Hospital

    RECRUITING

    Concord, 2139, Australia

  • Hosp Univ Fund Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen Rocio

    RECRUITING

    Seville, 41013, Spain

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31100, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13273, France

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, 6009, Australia

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