Phase III Study of TranspoCART19 CAR-T Cell Therapy for Adults with Relapsed or Refractory B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new treatment called TranspoCART19 for patients with relapsed or refractory B-cell lymphoma, a type of blood cancer. This Phase III trial aims to find the maximum tolerated dose and response rates of this therapy in patients whose prognosis is less than two years. The study is open-label and conducted at multiple centers in a national setting. The treatment involves autologous peripheral blood T lymphocytes that are expanded and genetically modified using a technology called Sleeping Beauty family transposons to express a chimeric antigen receptor targeting CD19. In Phase I, three dose levels of TranspoCART19 cells will be tested to determine the safest dose, followed by Phase II, where patients will receive the maximum tolerated dose determined earlier. Up to 27 patients will be included in the expansion phase, including those from Phase I. Participants will be followed for 36 months after treatment to assess various outcomes. Assessments include measuring maximum tolerated dose at 1 month, treatment efficiency at 3 months, and ongoing monitoring of toxicity, response rates, survival outcomes, and general well-being at multiple time points up to 36 months. The study involves regular clinical evaluations to track safety and effectiveness of the investigational therapy over time.

Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology