Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Complete molecular response (CMR) rate
Complete molecular response (CMR) rate after CD19 CAR-T cell therapy
Time frame: Up to 1 month after CAR-T cells infusion
Complete molecular response (CMR) rate
Complete molecular response (CMR) rate after CD22 CAR-T cell therapy
Time frame: Up to 1 month after CAR-T cells infusion
Leukemia-free survival (LFS)
From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Overall survival (OS)
From the first infusion of CD19 CAR-T cells to death or the last visit
Time frame: Up to 2 years after CD19 CAR-T cells infusion
cumulative incidence of relapse (CIR)
From the complete remission to relapse
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Time frame: Through study completion, an average of 2 years
Characterization of relapse
Including expression of CD19, CD22 and mutations in the ABL1 gene
Time frame: Through study completion, an average of 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.