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

NCT04702841 | Unknown Early Phase 1

• 1 other identifier: 2019-ky012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

CAR; Malignant Tumors

Keywords

CD7 Positive T-cell; γδT

Outcome Measures

Primary Outcomes (1)

• ORR 3

  3-month objective response rate

  three months after CAR-T cells infusion

Study Arms (1)

CAR-γδT

EXPERIMENTAL

Infusion,iv,0.2-5 ×10\^6/ kg,once.

Drug: Chimeric antigen receptor modified γδ T cells

Interventions

Chimeric antigen receptor modified γδ T cells 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.

Also known as: CAR-γδT cell infusion

CAR-γδT

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead
• Anhui Provincial Hospital: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Xingbing Wang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingbing Wang

CONTACT

13856007984; wangxingbing@ustc.edu.cn

Huimin Meng

CONTACT

0551-65728070; huimin.meng@persongen.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: June 3, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CN (1)