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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Collaborator: Anhui Provincial Hospital

Criteria

Inclusion Criteria:

1. 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;

2. Researchers believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation;

3. Patients should have indicators for detection or evaluation of disease, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;

4. They are 14-70 years old, regardless of gender or race;

5. Physical condition: ECoG score 0-2;

6. Cardiac function: left ventricular ejection fraction greater than or equal to 40%;

7. The expected survival time was > 12 weeks;

8. 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;

9. Patients have self-knowledge ability and can sign informed consent;

10. The guardian of the child patient agreed to sign the informed consent.

Exclusion Criteria:

1. pregnant or lactating women;

2. Uncontrolled infection;

3. Active HBV or HCV infection;

4. People living with HIV;

5. Less than 100 days after allogeneic hematopoietic stem cell transplantation;

6. Patients with acute GVHD or chronic GVHD after allogeneic hematopoietic transplantation;

7. Patients receiving GVHD treatment.