Study of U01 ssCART-19 CAR-T Cell Therapy for Relapsed or Refractory B-Cell Lymphoma in Patients Aged 2 to 75 Years

What this Trial Is About

This research aims to evaluate the efficacy and safety of U01 ssCART-19, a CD19-targeted CAR-T cell therapy engineered with an IL-6 silencing element, in patients with relapsed or refractory B-cell lymphoma. The study is a single-arm, open-label clinical trial involving participants aged 2 to 75 years who have specific treatment histories and disease status as defined by clinical guidelines. The primary focus is to assess treatment responses and adverse events in this patient group. Participants will receive lymphodepletion preconditioning with cyclophosphamide and fludarabine over three consecutive days before infusion of the ssCART-19 cells. The study includes a treatment period where the experimental CAR-T cells are administered following the conditioning regimen. There are no comparator groups in this single-arm study, and the intervention is given under careful medical supervision. During the study, participants will be closely monitored for adverse events during the first 28 days after CAR-T cell infusion. Researchers will evaluate objective response rate, duration of response, overall survival, and progression-free survival up to two years post-infusion. Additional assessments include pharmacokinetics and pharmacodynamics of the ssCART-19 cells. Participants will undergo regular clinical evaluations, laboratory tests, and imaging to measure treatment effects and safety throughout the follow-up period extending up to two years.

Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma