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Experimental immune cell therapy for AML shows promise but trial halted early

NCT ID NCT04511130

Disease control Sponsor: Marker Therapeutics, Inc. 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a treatment called MT-401, which uses specially trained immune cells from a donor to fight acute myeloid leukemia (AML) after a stem cell transplant. The goal was to see if these cells could prevent or treat relapse. The trial enrolled 92 people but was stopped early. The approach aims to control the disease, not cure it, as patients still need ongoing monitoring and care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

92 people

The number who actually took part.

Started

Oct 2020

Finished

Mar 2024

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 1. First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as: * Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or * Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as * First relapse (MRD+ or frank relapse) post-HSCT * Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT * Safety Lead-in defined as patients who fit all the criteria for Group 2 only 2. Are ≥18 years of age 3. Karnofsky/ Lansky score of ≥60 4. Life expectancy ≥12 weeks 5. Adequate blood, liver, and renal function * Blood: Hemoglobin ≥7.0 g/dL (can be transfused) * Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal * Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min 7\. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant. 8\. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit Exclusion Criteria 1. Clinically significant or severely symptomatic intercurrent infection 2. Pregnant or lactating 3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401 4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401 5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia Stem cell transplantation

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic Cancer Center-Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinical Cancer Center-Florida

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Moores Cancer Center at University of Californa San Diego

    La Jolla, California, 92093, United States

  • UCLA Department of Medicine

    Los Angeles, California, 90095, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Chicago

    Chicago, Illinois, 77027, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • Weill Cornell Medicine | NewYork-Presbyterian

    New York, New York, 10027, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 303222, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06519, United States

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