Open-Label Phase 12 Study to Evaluate Safety and Effectiveness of U01 ssCART-19 Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of U01 ssCART-19, a modified anti-CD19 CAR T-cell therapy, in patients with refractory or recurrent B-cell lymphoma. This open-label phase 1 and phase 2 study focuses on a new approach that uses small hairpin RNA technology to reduce IL-6 secretion, aiming to lower the risk of serious complications like cytokine release syndrome and neurotoxicity during CAR T-cell treatment. Participants will receive the ssCART-19 therapy, which involves autologous T cells modified to silence the IL-6 gene. All enrolled patients are treated with this experimental therapy as part of a single-arm study. The study follows patients over time to observe treatment response and monitor side effects closely. During the trial, participants will undergo regular assessments including safety monitoring from day 1 to week 4, and follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months to evaluate response and survival outcomes. Researchers will also track CAR T-cell behavior and inflammatory marker levels in blood up to 3 months post-infusion. The total participation time may extend up to two years, with ongoing evaluations of health and disease status.

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma