This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Subjects with relapsed/refractory B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography(CT)/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography(PET), and blood draws. Subjects will receive preconditioning chemotherapy prior to the infusion of human CD19 targeted DASH CAR-T Cells injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of human CD19 targeted DASH CAR-T cells. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Autologous genetically modified anti-CD19 CAR transduced T cells
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGDose limited toxicity (DLT)
Safety Indicators
Time frame: 28 days post infusion
Pharmacokinetics parameters - the highest concentration of Human CD19 Targeted DASH CAR-T Cells amplified in peripheral blood after reinfusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacokinetics parameters - the time to reach the highest concentration of Human CD19 Targeted DASH CAR-T Cells amplified in peripheral blood after reinfusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacokinetics parameters - the 28-day area under the curve of Human CD19 Targeted DASH CAR-T Cells amplified in peripheral blood after reinfusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacodynamics characteristics - the detection values of IL-6, IFN-γ, IL-15 cytokines in peripheral blood
Effectiveness Metrics
Time frame: 2 years post infusion
Overall response rate (ORR, include CR and CRi) after administration
Effectiveness Metrics
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Effectiveness Metrics
Time frame: 2 years post infusion
Overall Survival (OS) after administration
Effectiveness Metrics
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Time frame: 2 years post infusion