γδ T Cell Therapy for Relapse Prevention in High-Risk AML Post-Transplant

A Clinical Study on the Safety and Efficacy of γδ T Cells in Preventing Relapse After Allogeneic Transplantation in High-risk Acute Myeloid Leukemia Patients

This is a prospective, double-arm, single-center, randomized controlled single-blind clinical study

This study is a prospective, single-center, two-arm, single-blind randomized controlled clinical trial to evaluate the safety and efficacy of γδ T cell infusion in preventing recurrence in patients with high-risk AML after allogeneic transplantation.

Inclusion Criteria:

1. Patients voluntarily sign informed consent and are expected to complete the follow-up examination and treatment of the study procedures;

2. Age 18-65 years old (including cut-off value), gender is not limited;

3. AML patients have one of the high-risk factors for recurrence after allogeneic hematopoietic stem cell transplantation;

4. AML patients need to meet 30±5 days after the end of allogeneic transplant therapy;

5. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);

6. ECOG performance status score of 0-3 points and expected survival greater than 3 months ;

7. Have appropriate organ function:

   1. Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN);
   2. Aspartate aminotransferase (AST) ≤ 3 times ULN;
   3. Total bilirubin ≤1.5 times ULN;
   4. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥ 60 mL/min;
   5. Hemoglobin ≥ 50g/L (must not have received transfusion support within 7 days prior to laboratory tests);
   6. Room oxygen saturation ≥92%;
   7. Left ventricular ejection fraction (LVEF) ≥ 45%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings;
   8. Without clinically significant pleural effusion;

Exclusion Criteria:

1. Other malignant tumors within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary carcinoma of the thyroid, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
2. Patients have a severe allergic history;
3. The patient has severe heart disease;
4. The patient has severe respiratory system disease;
5. Those with grade III~IV acute GVHD or extensive chronic GVHD;
6. Patients who are using (or willing to use) other maintenance therapy drugs after hematopoietic stem cell transplantation and have proven that this maintenance therapy drug is not conducive to the persistence of γδ T cells in vivo;
7. Active neurological autoimmune or inflammatory diseases, amyotrophic lateral sclerosis (ALS), and clinically significant active cerebrovascular disease;
8. Patients with severe mental illness;
9. Alcoholics or those with a history of drug abuse;
10. Clinically significant active cerebrovascular disease;
11. Those who have participated in other clinical studies within 1 month before screening and have not interfered with the safety and efficacy of this study drug as assessed by the investigator are allowed to be included in the study, such as non-interventional observational studies;
12. Pregnant or lactating women, and female subjects who plan to become pregnant within 1 year after cell reinfusion or male subjects whose partners plan to become pregnant within 1 year after their cell reinfusion;
13. Any unsuitable to participate in this trial judged by the investigator.