Safety and Efficiency of γ9δ2 T Cell Against Post-transplant Acute Leukemia/Myelodysplastic Syndrome Relapse

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 20
• Participant gender: All

Summary

This study investigates the potential curative properties of ex-vivo expanded γ9δ2 T-cells obtained from a suitable donor for patients with relapsed acute leukemia or myelodysplastic syndrome after allogeneic hematopoietic stem cell transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Aclacinomycins; Cytarabine; Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

1. Patients with relapsed acute leukemia or myelodysplastic syndrome after allogeneic hematopoietic stem cell transplantation；

2. Age criteria: 18-65 years;

3. Weight criteria: > 40kg;

4. Organ function criteria:

Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%. Pulmonary function:

Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;

5. Life expectancy of at least 4 months;

6. GCOG (Eastern Cooperative Oncology Group) score ≤ 2;

7. Patients able to understand and sign written informed consent.

Exclusion Criteria:

1. GVHD (graft versus host disease) ≥ grade Ⅱ；

2. Thrombotic microangiopathy；

3. Posttransplant lymphoproliferative disorders；

4. Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；

5. Patients with chronic diseases that require treatment with immune agents or hormones;

6. Suffering from systemic autoimmune disease or immunodeficiency disease;

7. Systemic use of steroids;

8. Allergic constitution;

9. Hemorrhagic disease or coagulation disorders;

10. Patients participating in other clinical trials within 30 days prior to enrollment;

11. Patients receiving radiotherapy within 4 weeks prior to enrollment;

12. Pregnant or breastfeeding women;

13. According to the researcher's judgment, the patient has other unsuitable conditions.