Study of CD30 CAR-T Cell Therapy for Treating Relapsed or Refractory CD30 Positive Lymphoma Evaluating Safety, Effectiveness, and Dosage in Patients Aged 15 to 80 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD30 CAR-T cell therapy in treating patients with CD30-positive relapsed or refractory lymphoma. This prospective, open-label study aims to understand how this therapy works in the body and how different doses may impact treatment outcomes. The trial plans to enroll 15 subjects aged 15 to 80 years who have not responded to or relapsed after previous treatments including stem cell transplantation or brentuximab vedotin therapy. Participants will receive a single intravenous infusion of autologous CD30 CAR-T cells at one of three dose levels 1 million, 2 million, or 5 million CAR-positive T cells per kilogram of body weight. The infusion is performed using a blood transfusion apparatus with a filter and saline rinsing. The study will assess the safety, dose-limiting toxicities, and efficacy of the treatment, as well as monitor the metabolism of the infused cells in the patients. During the study, participants will be closely monitored for responses and side effects over six months to evaluate overall response rates. Additional follow-up for disease-free and overall survival will continue for up to three years. Assessments include clinical evaluations, laboratory tests, imaging according to the Lugano 2014 criteria, and performance status measures. Safety monitoring focuses on organ function, blood counts, and potential toxicities related to the therapy. The total duration of participation may extend up to three years to fully understand treatment impact and safety.

CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma