Ireland
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Recruiting Phase 1

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.

NCT06641648 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-11-01
Last updated
2026-08-05

Condition(s) studied

Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia (AML) RelapseNK Cell

Investigational drug(s) / intervention(s)

NK cell

NK cell: Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Dose limiting toxicities (DLTs) — 1 month
    Dose limiting toxicities (DLTs)
  • Treatment-related adverse events — 1 month
    Treatment-related adverse events

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641648 on ClinicalTrials.gov ↗ ← All trials in China