Study of Chemotherapy Plus CAR-T Cell Therapy for Adults with Newly Diagnosed Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are investigating a treatment approach for adults newly diagnosed with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia Ph- B-ALL. This study evaluates combining chemotherapy with CAR-T cell therapy as a consolidation method after patients achieve complete remission through chemotherapy. The goal is to reduce chemotherapy cycles and related side effects, shorten hospital stays, and potentially improve survival and quality of life. Key outcomes include 2-year disease-free survival, overall survival, event-free survival, molecular remission rates, relapse rates, treatment-related toxicities, and quality of life, with an interim analysis focused on 1-year disease-free survival. The treatment involves a single infusion of murine-derived second-generation CD19 CAR-T cells with a 4-1BB co-stimulation domain, dosed at 1x106 CAR-positive cells per kilogram. Patients receive CAR-T cells as consolidation therapy after achieving remission with a pediatric-inspired chemotherapy regimen combined with venetoclax. This combination is designed to enhance remission depth and reduce chemotherapy exposure. Participants will be monitored up to 2 years for disease-free survival and up to 5 years for overall and event-free survival. Assessments include measuring minimal residual disease using flow cytometry and next-generation sequencing, tracking relapse incidence, adverse events, and quality of life. Continuous evaluations and safety monitoring will occur throughout the study period, with informed consent obtained before screening and enrollment.

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL