Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
γδT cells belong to the innate immune system and have a powerful anti-tumor effect. Leukemia patients transplanted with allogeneic hematopoietic stem cells have an important role in controlling leukemia recurrence. Although adoptive immunotherapy using in vitro expanded γδT cells has achieved significant results in patients with solid tumors, infusion of donor γδT cells in leukemia patients undergoing allogeneic hematopoietic stem cell transplantation to prevent leukemia recurrence has not been reported. . This clinical study intends to initially observe the safety and effectiveness of donor γδT cell infusion to prevent recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to further improve the transplantation effect of these patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
5
γδT
No.188 Shizi Street
Suzhou, Jiangsu, China
RECRUITINGIdentification of the dose limiting toxicity (DLT)
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
Time frame: 4 weeks after γδT infusion
The incidence of serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) after γδT infusion
Time frame: 4 weeks after γδT infusion
Disease-free survival time(DFS)
γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause
Time frame: about 2 years after γδT infusion
Overall survival (OS)
The time from the subject receiving γδT cell infusion treatment to death (for any reason)
Time frame: about 2 years after γδT infusion
Duration of remission after administration (DOR)
γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause
Time frame: about 2 years after γδT infusion
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