This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with relapsed and refractory acute B-cell leukemia
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: 28 days
The incidence of all grade TEAEs and ≥3 grade TEAEs
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Time frame: Up to 2 years after ThisCART19A infusion
Objective response rate
Objective response rate (ORR = CR + CRi) of ThisCART19A within 3 months after administration
Time frame: At Month 1, 2, 3
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR
Time frame: 3 months
Changes in cytokine level after ThisCART19A infusion.
Calculate the change of cytokine level in peripheral blood by flow cytometry after ThisCART19A infusion. Cytokines include IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、IL-12、IL-17、TNF-α、IFN-γ、TGF-β.
Time frame: 3 months
Changes in immune effect cells count after ThisCART19A infusion.
Calculate the change of immune effect cells count in peripheral blood by flow cytometry after ThisCART19A infusion. Immune effect cells include T cell, B cell, NK cell.
Time frame: 3 months
MRD response rate
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Percentage of participants with minimal residual disease (MRD) response in patients with CR (complete response) and CRi (CR with incomplete blood count recovery) ; MRD Response is defined as leukemic cells in bone marrow \<0.01% by flow cytometry (sensitivity at least 0.001%)
Time frame: 24 months