This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load. The Main research objectives: To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma. The Secondary research objectives: To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients will be treated with CD7 CAR-T cells
Hebei yanda Ludaopei Hospital
Beijingcun, Hebei, China
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: First 1 month post CAR-T cells infusion
Remission Rate
To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.
Time frame: 3 months post CAR-T cells infusion
duration of response (DOR)
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
Time frame: 3 months post CAR-T cells infusion
progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Time frame: First 1 month post CAR-T cells infusion
CAR-T proliferation
percentage of CD7 CAR- T cells measured by flow cytometry method
Time frame: 3 months post CAR-T cells infusion
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