Status:
UNKNOWN
CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
Anhui Provincial Hospital
Conditions:
CAR
Malignant Tumors
Eligibility:
All Genders
14-70 years
Phase:
EARLY_PHASE1
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...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04702841
Start Date
June 3 2020
End Date
December 1 2022
Last Update
March 8 2021
Active Locations (1)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000