Can donor immune cells fight leukemia relapse after transplant?
NCT ID NCT06641648
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether infusing natural killer (NK) cells from a healthy donor, combined with low-dose interleukin-2 (IL-2), can safely help treat acute myeloid leukemia (AML) that has returned after a stem cell transplant. The study involves about 12 adults with AML relapse and aims to evaluate the safety, tolerability, and preliminary effectiveness of this approach. Participants will receive the donor NK cell infusion and IL-2, and researchers will monitor for side effects and signs of remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donor natural killer (NK) cells combined with low-dose interleukin-2 (IL-2)
- What this could lead to
- If successful, this approach could offer a new treatment option for patients with AML that returns after a stem cell transplant, potentially improving remission rates.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. There may be risks such as graft-versus-host disease or other treatment-related 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
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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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2027
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 years and older
- 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: * Age ≥ 18 years old,; * Expected survival period ≥ 3 months; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; * The diagnosis of AML who received allo-HSCT, and met the following criteria: A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment; C. Degree II and above acute graft-versus-host disease did not occur after transplantation; D. Available allogeneic hematopoietic stem cell transplant donors. -Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 45%; * Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; * Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Central nervous system involved; * Patients who received the following anti-tumor therapies prior to infusion: A. Systemic use of hormones within 3 days prior to infusion (except for patients with inhaled corticosteroids); B. Systemic anti-tumor therapy within 2 weeks or within 5 drug half-lives (whichever is shorter); C. Radiotherapy within 4 weeks; D. DLI within 6 weeks; E. Intrathecal injection within 1 week; F. Received CAR-T, CAR-NK or other modified cell therapy within 6 months; * Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis. * History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; * Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; * Women who are pregnant (urine/blood pregnancy test positive) or lactating; * Suffering from a serious autoimmune disease or immunodeficiency disease; * Known alcohol dependence or drug dependence; * According to the investigator\'s judgment, the patient has other unsuitable grouping conditions.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100034, China
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- Can a new drug trio overcome venetoclax resistance in leukemia?
- Can engineered cells beat relapsed blood cancers?
- Can a new pill outsmart resistant leukemia?