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Experimental cell therapy for tough leukemia shows early promise but trial halted

NCT ID NCT05886491

Disease control Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tested a new cell therapy called GDX012 in 16 people with acute myeloid leukemia (AML) that had come back or not responded to standard treatment. The main goals were to check safety, find the best dose, and see if the therapy could control the cancer. The study was terminated early, so results are limited.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

16 people

The number who actually took part.

Started

Jul 2023

Finished

Nov 2025

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. Total body weight of ≥40 kg. 2. Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including: 1. Relapsed AML is defined as ≥5% blasts in the bone marrow (BM) or peripheral blood at any time after achieving a CR, CRh, Cri, or MLFS. 2. Refractory AML is defined as failure to achieve a CR, CRh, Cri, or MLFS after 1 of the following regimens: i. Two courses of intensive induction chemotherapy. ii. At least 2 cycles of hypomethylating agent (HMA) or low-dose, cytarabine-based combination regimen. iii. At least 4 cycles of HMA monotherapy. 3. During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT). 4. Must have an anticipated life expectancy of \>3 months before lymphodepletion. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol. Exclusion criteria: 1. Diagnosis of acute promyelocytic leukemia. 2. Has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol. 3. Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy. 4. Active central nervous system (CNS) involvement. 5. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg. cervix, bladder, breast) low grade prostate cancer without treatment requirement unless in remission without treatment for ≥2 years.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia

As listed by the trial registrant

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

Leukemia

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • Sarah Cannon/CBCI

    Denver, Colorado, 80218, United States

  • Thomas Jefferson University

    New York, New York, 10065, United States

  • Tri-Star BMT/Sarah Cannon Nashville

    Nashville, Tennessee, 37203, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35205, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.