Immune cell boost could keep leukemia at bay after transplant
NCT ID NCT05015426
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?