This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate (ORR)
Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.
Time frame: 1 year
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Time frame: 1 year
Complete relapse rate(CR)
Number of patients who achieved complete response after treatment by CD7 CAR-T cell.
Time frame: 1 year
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Time frame: 1 year
Progression-free survival(PFS)
PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Time frame: 1 year
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Time frame: 1 year
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