Tests donor natural killer cells with low-dose interleukin-2 for leukemia relapse
Tests donor immune cells plus low-dose interleukin-2 in adults with leukemia returning after transplant.
Plain-language title generated from the registry record
Registry title: A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined With Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) came back after a donor stem cell transplant. It tests donor NK cells with low-dose interleukin-2.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- AML that relapsed after an allogeneic stem cell transplant (leukemia cells back in blood, 5% or more blasts in bone marrow, or cells outside the marrow), or only MRD positive. No acute graft-versus-host disease of degree II or above after the transplant. A donor must be available.
- Earlier treatment
- Must have had an allogeneic hematopoietic stem cell transplant. Before the infusion: no hormones taken by mouth or injection within 3 days, no systemic anti-tumor therapy within 2 weeks, no radiotherapy within 4 weeks, no DLI within 6 weeks, no CAR-T, CAR-NK or other modified cell therapy within 6 months.
- Biomarker or test result
- MRD positive in bone marrow (by flow cytometry) is one way in, if there is no full relapse.
Main reasons for not taking part
- Leukemia in the central nervous system
- Active infection needing IV treatment, including HBV, HCV, HIV, syphilis or active tuberculosis
- Pregnant or breastfeeding women
- Serious autoimmune or immunodeficiency disease
- Cannot use effective contraception for 1 year after enrollment
Read by machine on 9 November 2026.
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT06641648
- Record updated
- 5 August 2026
- Original description
This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).Read full original descriptionShow less
A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined With Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.
This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Inclusion: 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:; 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: Patients who received the following anti-tumor therapies prior to infusion:; 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; Known alcohol dependence or drug dependence; History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; Suffering from a serious autoimmune disease or immunodeficiency disease; According to the investigator\'s judgment, the patient has other unsuitable grouping conditions; Central nervous system involved; 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.