CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors

Study Overview
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Brief Summary
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This is a study on the clinical application of chimeric antigen receptor modified γδ T cells (CAR - γδ T cells) in relapsed and refractory CD7 Positive T cell-derived malignant tumors.The main purpose of this study was to evaluate the efficacy of car - γ δ T cell infusion in patients with relapsed and refractory CD7 Positive T cell-derived malignancies.

Detailed Description
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γδT cells are known as a great candidate for car-t cells. Although they only account for 2% - 5% of all T cells in our body, they are a natural killer. CD7 is recognized as a sensitive marker of T-ALL, and its expression level on T-ALL cells is opposite to CD3: compared with normal T cells, the expression level of CD7 on T-ALL cells is significantly increased (P < 0.001), while the expression level of CD3 on T-ALL cells is significantly decreased (P < 0.001). At the same time, CD7 expression is absent in about 10% of normal T cells, and these CD7 negative T cells have the ability of normal T cells to express cytokines. Therefore, CD7 has become a potential target for the treatment of T-ALL because of its specificity and safety.

Official Title
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Clinical Application of Chimeric Antigen Receptor Modified γδ T Cells（CAR - γ δ T Cells） in Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors

Conditions
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CAR, Malignant Tumors

Intervention / Treatment
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* Drug: Chimeric antigen receptor modified γδ T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients must be patients with relapsed or refractory CD7 Positive T cell-derived malignancies, who have at least one course of standard regimen chemotherapy and one course of salvage regimen chemotherapy and have poor effect; Researchers believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation; Patients should have indicators for detection or evaluation of disease, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR; They are 14-70 years old, regardless of gender or race; Physical condition: ECoG score 0-2; Cardiac function: left ventricular ejection fraction greater than or equal to 40%; The expected survival time was > 12 weeks; Serum creatinine (CR) ≤ 1.5 × ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; Patients have self-knowledge ability and can sign informed consent; The guardian of the child patient agreed to sign the informed consent. Exclusion Criteria: pregnant or lactating women; Uncontrolled infection; Active HBV or HCV infection; People living with HIV; Less than 100 days after allogeneic hematopoietic stem cell transplantation; Patients with acute GVHD or chronic GVHD after allogeneic hematopoietic transplantation; Patients receiving GVHD treatment.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR-γδT<br>Infusion,iv,0.2-5 ×10^6/ kg,once. | Drug: Chimeric antigen receptor modified γδ T cells<br>* Dosage: the total dosage of reinfusion is 0.2-5 × 10^6 / kg, which is determined according to the body weight of the subject and the effective content of cell preparation.<br>* Other names: CAR-γδT cell infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR 3 | 3-month objective response rate | three months after CAR-T cells infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD7 Positive T-cell, γδT