Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL

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.

NCT Number	NCT07575919
Lead Sponsor	Liping Dou
Conditions	B-cell Acute Lymphoblastic Leukemia
Enrollment	20 participants
Start Date	2026-01-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-15