Donor NK Cell Infusion with Low-Dose IL-2 for AML relapse after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm, open-label Phase 1 study to assess safety, tolerability, and preliminary efficacy of donor NK cells given after relapse of AML post-allogeneic hematopoietic stem cell transplantation, followed by low-dose IL-2. It uses a dose-escalation design with non-genetically modified NK cells from a healthy donor. Participants are adults with relapsed AML after allo-HSCT, with no GVHD prevention implemented around infusion, and researchers will monitor dose-limiting toxicities, adverse events, disease response, and PK/PD after infusion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yujun Dong, Docter — Peking University First Hospital
• Study coordinator: Yujun Dong, Docter
• Email: dongy@hsc.pku.edu.cn
• Phone: 8683575680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.