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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NK cell.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia (AML) Relapse, NK Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed description
This is a dose-escalation study of non-genetically modified natural killer cells derived from a healthy donor. The relapsed AML patients after allo-HSCT will receive donor NK cells injection s followed by low-dose interleukin-2. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
Interventions
- Drug NK cell
Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.
Primary outcome measures
- Dose limiting toxicities (DLTs) [Time frame: 1 month]
- Treatment-related adverse events [Time frame: 1 month]
Secondary outcome measures (3)
- Complete response (CR) [Time frame: 3 months]
- Proportion of subjects with minimal-residual disease (MRD) negative response [Time frame: 3 months]
- Peak levels of donor NK cells (maximum concentration or Cmax) [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06641648 · PKUFH JDCO2