Clinical Study Protocol to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia
This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation.
• Voluntarily signs the informed consent form and is expected to be able to complete the follow-up examinations and treatments required by the study procedures.
• Age 18 to 65 years (inclusive), regardless of gender.
• Patients have one of the high-risk factors for relapse before allogeneic hematopoietic stem cell transplantation：①Meets the diagnostic criteria for relapsed or refractory disease as defined by the Chinese Guidelines for Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition);②Hyperleukocytosis (≥100×10⁹/L) with concomitant central nervous system leukemia (CNSL); ③Positive minimal residual disease (MRD) before transplantation; ④Populations defined as having poor prognosis;⑤Myelodysplastic syndromes transformed to or secondary acute myeloid leukemia.
• Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation.
• The subject has recovered from toxicities of previous therapies, defined as CTCAE grade \<2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).
• Eastern Cooperative Oncology Group(ECOG) performance status score of 0-3 and an estimated life expectancy greater than 3 months.
• Adequate organ function is defined as:
‣ Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);
⁃ Aspartate aminotransferase (AST) ≤3 × ULN;
⁃ Total bilirubin ≤1.5 × ULN;
⁃ Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min;
⁃ Hemoglobin ≥50g/L (must not have received transfusion support within 7 days prior to laboratory testing);
⁃ Room air oxygen saturation ≥92%;
⁃ Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography without pericardial effusion and no clinically significant ECG findings;
⁃ No clinically significant pleural effusion.