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.
About this study
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).
- Condition
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia (AML) Relapse, NK Cell
- Tested
- NK cell
- Sponsor
- Peking University First Hospital
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 17
- Minimum age: 18 years
- Study condition: Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia (AML) Relapse, NK Cell
- 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:
- 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;
- 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;
- Degree II and above acute graft-versus-host disease did not occur after transplantation;
- Available allogeneic hematopoietic stem cell transplant donors.
- Adequate organ function: A.
- Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN;
- Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min;
- 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 15
- Central nervous system involved;
- Patients who received the following anti-tumor therapies prior to infusion:
- Systemic use of hormones within 3 days prior to infusion (except for patients with inhaled corticosteroids);
- Systemic anti-tumor therapy within 2 weeks or within 5 drug half-lives (whichever is shorter);
- Radiotherapy within 4 weeks;
- DLI within 6 weeks;
- Intrathecal injection within 1 week;
- 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
1 site, 1 recruiting
Peking University First Hospital
Beijing, Beijing Municipality, China
Contact
-
Yujun Dong, Docter
8683575680 dongy@hsc.pku.edu.cn
-
Bingjie Wang
Potential match only. Final eligibility is determined by the study team.