The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies
This study is single-armed,open lable,dose escalation clinical trial.The main purpose is to evaluate the safety and efficacy of anti-CD7 CAR-T cells in relapsed/refractory patients with CD7 positive T cell malignancies,including T lymphoblastic lymphoma/leukemia ,T-cell non-Hodgkin lymphoma(peripheral T cell lymphoma,NOS,angioimmunoblastic T cell lymphoma and anaplastic large cell lymphoma).There will be three CAR T cell dose groups:0.25\*10\^6 cells per kilogram of body weight;0.5\*10\^6 cells per kilogram of body weight,1 \*10\^6 ells per kilogram of body weight.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients
Xianmin General Song
Shanghai, China
Incidence of Treatment-Emergent Adverse Events
The occurence of study related adverse effects defined by NCI CTCAE5.0
Time frame: 28 days post infusion
CAR-T cell expansion
Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell expansion after infusion
Time frame: 2 years post infusion
CAR-T cell persistence
Using flow cytometry to reveal cell surface expression of the CAR protein on T cells;and using quantitative polymerase chain reaction to detect DNA copies of the transgene irrespective of gene expression(per ug DNA) to evaluate anti-CD7 CAR-T cell persistence after infusion
Time frame: 2 years post infusion
Number of CD7+ lymphocytes of peripheral blood
To evaluate CD7 positive cells of peripheral blood after infusion
Time frame: 2 years post infusion
Total response rate (ORR) after administration
CR+CRi for T-ALL ;CR+PR for T cell lyphoma and T lymphoblastic lymphoma
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Overall survival(OS) after administration
Overall Survival (OS)after administration
Time frame: 2 years post infusion
Progression Free Survival (PFS) after administration
Progression Free Survival (PFS) after administration
Time frame: 2 years post infusion
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