To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells.
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of Human CD19-CD22 Targeted T Cells Injection. To preliminary observe the effect of Human CD19-CD22 Targeted T Cells Injection in relapsed/refractory B-cell acute lymphoblastic leukemia, and to explore the clinically applicable dose and reinfusion regimen for phase II. Participants with relapsed/refractory B-cell Acute Lymphoblastic Leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, Computedtomography (CT)/ Magnetic Resonance Imaging(MRI) / Positron Emission Tomography(PET), and blood draws. Participants receive chemotherapy prior to the infusion of CD19-CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19-CD22 CAR+ T cells. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
One time single predetermined dose level CAR-positive T cells will be utilized based on the NMPA approved product label.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Dose limited toxicity(DLT)
Safety indicators
Time frame: 28 days post infusion
Adverse events;
Safety indicators
Time frame: 28 days post infusion
Pharmacokinetic parameters: the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Pharmacokinetic parameters: the time to reach the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Pharmacokinetic parameters: the 28-day area under the curve of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Pharmacodynamic parameters: the detection counts of CD19 or CD22 positive B cells in peripheral blood;
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Pharmacodynamicparameters: the detection values of IL-6, CRP, and IL-15 cytokines in peripheral blood;
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall response rate (ORR) after administration
Effectiveness Metrics
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Progress Free Survival (PFS) after administration
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
Overall Survival (OS) after administration
Effectiveness Metrics
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)
The immunogenicity of Human CD19-CD22 Targeted T Cells Injection. (the detection of human anti-mouse antibody)
Safety indicators
Time frame: 2 years post infusion(the last subject will be followed up to 15 years after infusion)