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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Yujun Dong, Docter
dongy@hsc.pku.edu.cn
8683575680
Backup
Bingjie Wang
wbj880202@163.com
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 12
Treatments
Experimental: NK cell treatment in AML replase after HSCT
The relapsed AML patients will receive donor NK cells injections for a total dose of twice per 2 weeks up to 3 dose levels (1.0×108 cells/dose,5.0×108 cells/dose,2.0×109 cells/dose), followed by low-dose interleukin-2 (1mIU ih, Qd) for 28 days.
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov