Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL
An Exploratory Study on Targeted CD22/CD19 Chimeric Antigen Receptor (CAR)-T Cell Immunotherapy for Enhanced Consolidation Therapy of Standard-risk B-cell Acute Lymphoblastic Leukemia
Liping Dou
20 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
This is a single-center, open-label, single-arm prospective study designed to evaluate the safety, tolerability, and efficacy of dual-target CD22/CD19 chimeric antigen receptor (CAR)-T cell therapy as consolidation treatment in patients with standard-risk B-cell acute lymphoblastic leukemia (B-ALL) in remission. Eligible patients will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepleting chemotherapy and CAR-T cell infusion. Patients will be closely monitored for safety, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and infections. Efficacy endpoints include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), relapse rate, and mortality. Exploratory analyses will assess CAR-T cell expansion kinetics and clonal evolution. The total follow-up duration is planned to be 2 years.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Autologous CD22/CD19 dual-target chimeric antigen receptor T cells
Locations(1)
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NCT07575919