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

NCT ID: NCT04702841

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

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.

Conditions

CAR; Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-γδT

Infusion,iv,0.2-5 ×10\^6/ kg,once.

Group Type: EXPERIMENTAL

Chimeric antigen receptor modified γδ T cells

Intervention Type: DRUG

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.

Interventions

Chimeric antigen receptor modified γδ T cells

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.

Intervention Type: DRUG

Other Intervention Names

CAR-γδT cell infusion

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xingbing Wang

Role: PRINCIPAL_INVESTIGATOR

No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingbing Wang

Role: CONTACT

wangxingbing@ustc.edu.cn

13856007984

Huimin Meng

Role: CONTACT

huimin.meng@persongen.com.cn

0551-65728070

Facility Contacts

xingbing wang, doctor

Role: primary

wangxingbing@ustc.edu.cn

+8613856007984

Other Identifiers

2019-ky012

Identifier Type: -

Identifier Source: org_study_id