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 | Recruiting Phase 1 DMC

• 1 other identifier: PKUFH JDCO2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Myeloid Leukemia (AML) Relapse; NK Cell; Acute Myeloid Leukemia (AML)

Keywords

AML; relapse; allogeneic hematopoietic stem cell transplantation.; NK cell

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs)

  Dose limiting toxicities (DLTs)

  1 month

• Treatment-related adverse events

  Treatment-related adverse events

  1 month

Secondary Outcomes (3)

• Complete response (CR)

  3 months

• Proportion of subjects with minimal-residual disease (MRD) negative response

  3 months

• Peak levels of donor NK cells (maximum concentration or Cmax)

  3 months

Study Arms (1)

NK cell treatment in AML replase after HSCT

EXPERIMENTAL

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.

Drug: NK cell

Interventions

NK cell DRUG

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

NK cell treatment in AML replase after HSCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yujun Dong, Docter

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujun Dong, Docter

CONTACT

8683575680; dongy@hsc.pku.edu.cn

Bingjie Wang

CONTACT

wbj880202@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of department of hematology

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)