γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse

Study Overview
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Brief Summary
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Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Detailed Description
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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

Official Title
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Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Leukemia, B-cell

Intervention / Treatment
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* Drug: γδT Cell infusion agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute leukemia patients undergoing salvage allogeneic hematopoietic stem cell transplantation Age 10-65,Any gender Expected lifetime>3months ECOG 0-2 DSA Negative Successful granulocyte implantation Liver and kidney function, heart and lung function meet the following requirements:①Creatinine≤1.5 ULN；②ALT/AST ≤5 ULN； ③Baseline oxygen saturation≥92%； ④Left ventricular ejection fraction≥50% Female subjects with fertility who had a negative pregnancy test within 48 hours before the infusion and were not breastfeeding; all subjects with fertility potential before enrolling in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures Signing informed consent patients must be able to understand and be willing to participate in this study, and sign informed consent at the same time Exclusion Criteria: Donor HBsAg or HBcAb positive and HBV DNA titer test is not within the normal reference value; donor or patient HCV antibody positive and peripheral blood HCV RNA positive; donor or patient HIV antibody positive; donor syphilis test positive Active central nervous system disease BMI index>35 Allergic to DMSO Graft-versus-host disease Septic shock Systemic steroid therapy is required during cell infusion or cell collection, or there are conditions that researchers believe may require steroid therapy during blood collection or during infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone are also allowed for physiological replacement therapy in patients with adrenal insufficiency Participated in another clinical trial within 4 weeks before enrolling in the study, or intend to participate in another clinical trial throughout the study According to the judgment of the investigator, it does not meet the situation of cell preparation Circumstances considered by other researchers to be inappropriate

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: γδT<br>γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once. | Drug: γδT Cell infusion agent<br>* γδT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification 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. | 4 weeks after γδT infusion | 
| The incidence of serious adverse events (SAEs) | The incidence of serious adverse events (SAEs) after γδT infusion | 4 weeks after γδT infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | about 2 years after γδT infusion | 
| Overall survival (OS) | The time from the subject receiving γδT cell infusion treatment to death (for any reason) | 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 | about 2 years after γδT infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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γδT, leukemia