This study is a open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells by intravenous and intrathecal administration, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.
Subjects with refractory/relapsed central nervous system involvement of B cell malignancies 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), Cerebrospinal fluid exam and blood draws. Subjects will receive preconditioning chemotherapy prior to the infusion of Human CD19-CD22 Targeted T Cells Injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of Human CD19-CD22 Targeted T Cells Injection. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous genetically modified anti-CD19/CD22 CAR transduced T cells
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Dose limited toxicity (DLT)
Safety Indicators
Time frame: 28 days post infusion
The occurrence rate of adverse events grade ≥ 3 assessed by NCI-CTCAE 5.0
Safety Indicators
Time frame: 28 days post infusion
Pharmacokinetics parameters - the highest concentration of Human CD19-CD22 Targeted 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-CD22 Targeted 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-CD22 Targeted T Cells amplified in peripheral blood after reinfusion
Effectiveness Metrics
Time frame: 2 years post infusion
The rate of CAR-T cells in cerebrospinal fluid
Effectiveness Metrics
Time frame: 2 years post infusion
The duration of CAR-T cells in cerebrospinal fluid
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 years post infusion
Overall response rate (ORR) at 3 months 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
Time frame: 2 years post infusion