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Immune cell boost could keep leukemia at bay after transplant

NCT ID NCT05015426

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial tests whether infusing specially grown donor immune cells (gamma delta T-cells) can prevent acute myeloid leukemia from returning in patients who are at high risk of relapse after a stem cell transplant. About 20 adults aged 18–75 will receive a single infusion of these cells. The study aims to find the safest dose and see if it improves leukemia-free survival.

What this could mean

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

Active substance
donor gamma delta T-cells (a type of immune cell)
What this could lead to
If it works, this could offer a new way to prevent leukemia from coming back after a stem cell transplant, without needing long-term drugs.
What could go wrong
This is a very early, small trial (20 people) focused on safety and dosing. The cells may cause graft-versus-host disease or fail to prevent relapse.

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

20 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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: * Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML * Have \< 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed * Karnofsky performance status (KPS) ≥ 70% during the study screening. * Free of symptomatic congestive heart failure or uncontrolled arrhythmia * Adequate organ function as defined per protocol * Negative serum pregnancy test * Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study. * Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: * Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function. * Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product). * Uncontrolled serious infection. * Morphologic relapse of leukemia at any timepoint after HCT. * Active central nervous system malignancy. * Pregnancy or lactation. * Treatment with another investigational drug or other intervention within 14 days of T-cell infusion

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

More trials for these conditions

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