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New hope for tough blood cancers? early trial of JNJ-89853413 begins

NCT ID NCT06618001

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called JNJ-89853413 in 64 people whose acute myeloid leukemia (AML) or myelodysplastic neoplasms (MDS) have come back or stopped responding to treatment. The main goal is to check safety and find the right dose, with a second part looking at whether it helps fight the cancer. It's a first-in-human study, so results are very preliminary.

What this could mean

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

Active substance
JNJ-89853413
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat blood cancers like AML or MDS.
What could go wrong
This is a very early Phase 1 trial with only 64 participants, so safety and dosing are still being figured out. It may not work or could have serious side effects.

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

64 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Nov 2026

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: * Have a diagnosis, per World Health Organization (WHO) 2022 criteria of: 1. relapsed/refractory acute myeloid leukemia (AML) 2. relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M) * Body weight greater than or equals to (\>=) 40 kilograms (kg) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 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) * Participants must have laboratory parameters in the required range Exclusion Criteria: * Has a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation * Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection * Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413 * Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413 * 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

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, Cb2 2qq, United Kingdom

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C1, Canada

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • University College London Hospitals

    London, W1T 7HA, United Kingdom

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

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