This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: Up to 28 days after ThisCART19A infusion
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
Relapse-Free Survival
Defined as the time from the infusion of ThisCART19A cells to the occurrence of hematologic relapse or death from any cause.Hematologic recurrence was defined as ≥5% of bone marrow lymphoblasts or extramedullary recurrence after CR or CRi
Time frame: 24 months
MRD response rate
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: 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
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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