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

Malignant Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702841
• Other study ID #: 2019-ky012
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 3, 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Contact: Xingbing Wang
• Phone: 13856007984
• Email: wangxingbing[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• CAR
• Malignant Tumors
• Neoplasms

Intervention

Drug:
• Chimeric antigen receptor modified ?d 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.

Locations

Country	Name	City	State
China	Anhui Provincial Hospital	Hefei	Anhui

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR 3	3-month objective response rate	three months after CAR-T cells infusion