Status:
UNKNOWN
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have acce...
Detailed Description
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem ...
Eligibility Criteria
Inclusion
- Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
- Age criteria: 18-65 years;
- Weight criteria: \> 40kg;
- 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;
- Life expectancy of at least 4 months;
- ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
- Patients able to understand and sign written informed consent.
Exclusion
- GVHD (graft versus host disease) ≥ grade Ⅱ；
- Thrombotic microangiopathy；
- Posttransplant lymphoproliferative disorders；
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
- Patients with chronic diseases that require treatment with immune agents or hormones;
- Suffering from systemic autoimmune disease or immunodeficiency disease;
- Systemic use of steroids;
- Allergic constitution;
- Hemorrhagic disease or coagulation disorders;
- Patients participating in other clinical trials within 30 days prior to enrollment;
- Patients receiving radiotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women;
- According to the researcher's judgment, the patient has other unsuitable conditions.
Key Trial Info
Start Date :
September 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04764513
Start Date
September 12 2021
End Date
April 1 2025
Last Update
March 28 2022
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China, 100853