Phase 1 Study of LUCAR-20SP Allogenic CAR-T Cell Therapy for Adults with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are exploring the use of LUCAR-20SP, an allogenic CAR-T cell therapy, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. This study is a prospective, single-arm, open-label clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor effects of LUCAR-20SP in this patient population. The study focuses on patients with specific types of B-cell lymphoma that have not responded to previous treatments or have relapsed. Participants will receive an infusion of LUCAR-20SP cells following a conditioning premedication regimen that includes cyclophosphamide and fludarabine. The trial includes several stages screening, pre-treatment with lymphodepleting chemotherapy, treatment with the LUCAR-20SP infusion, and follow-up. The treatment is designed to assess the appropriate dose and monitor the bodys response to this cellular therapy. During the study, participants will undergo various assessments including safety monitoring, evaluation of adverse events, and pharmacokinetic measurements in blood and bone marrow over at least two years after infusion. Researchers will also measure treatment responses such as objective response rate, time to response, duration of remission, progression-free survival, and overall survival. The study involves regular follow-up visits to track these outcomes and assess the development of antibodies against LUCAR-20SP, ensuring thorough monitoring of participants throughout the trial period.

A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma