Early Phase 1 Study of JY231 Injection for Safety and Initial Effectiveness in Treating B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of JY231 injection in treating B-cell acute lymphoblastic leukemia B-ALL. This early phase 1 clinical study aims to understand how well patients with B-ALL can tolerate the treatment and to observe any early signs of benefit. The research is sponsored by the 920th Hospital of Joint Logistics Support Force of Peoples Liberation Army of China. Participants receive JY231 injection through intravenous infusion, splenic artery infusion, or lymph node infusion at doses ranging from 1 to 10 x 106, 1 to 5 x 107, or 5 to 10 x 107 Transduction Units TU per kilogram. Before receiving the cell infusion, patients are treated with Fludarabine and Cyclophosphamide, with prior investigator evaluation required. The study measures responses and monitors adverse events over various time points up to two years after infusion. During the study, participants are monitored for treatment-related adverse events for up to 12 months and for maximum tolerated dose within 28 days after infusion. Effectiveness is assessed by overall response rates at 2, 4, 8, and 12 weeks, as well as the best overall response up to 24 weeks. Duration of remission, time to progression, progression-free survival, and overall survival are evaluated for up to two years. Participants undergo regular assessments including physical exams, laboratory tests, and imaging to track safety and treatment impact throughout the study period.

JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)