The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Department of Hematology, Navy General Hospital of PLA
Beijing, Beijing Municipality, China
RECRUITINGIncidence of Treatment Related Adverse Events
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.
Time frame: 1 year
Overall response rate (ORR)
Proportion of patients with reduction in tumor burden.
Time frame: 2 months
Overall survival (OS)
Time from study enrollment until death.
Time frame: 6 months
Minimal residual disease negative remission rate(MRD)
Proportion of MRD-negative patients.
Time frame: 2 months
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