A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Each subject receive CD19/CD22 CAR T-cells by intravenous infusion
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGComplete Molecular Response Rate after CD19 CAR-T Cell Therapy
Laboratory tests
Time frame: 28 days after infusion
Leukemia-Free Survival
Survival follow-up
Time frame: 2 years after infusion
Overall survival
Survival follow-up
Time frame: 2 years after infusion
Cumulative Incidence of Relapse
Laboratory tests
Time frame: 2 years after infusion
Complete Molecular Response Rate after CD22 CAR-T Cell Therapy
Laboratory tests
Time frame: 2 years after infusion
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