CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
For intravenous infusion
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
the incidence and severity of immune therapy related toxic reactions (irAEs)
Time frame: up to one month after the CAR-T infusion
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
CR rate on M1 and M3
Time frame: one month and three month after the CAR-T infusion
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
ORR(CR and PR) on M1 and M3
Time frame: one month and three month after the CAR-T infusion
long-term efficacy
DOR
Time frame: up to one year after the CAR-T infusion
long-term efficacy
PFS
Time frame: up to one year after the CAR-T infusion
long-term efficacy
OS
Time frame: up to one year after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CARgene copy numbers by qPCR
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Area under the plasma concentration versus time curve(AUC)
Time frame: up to one month after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Peak Plasma Concentration (Cmax)
Time frame: up to one mpnth after the CAR-T infusion
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