Study of Axicabtagene Ciloleucel Injection to Treat Chinese Adults with Relapsed or Refractory Follicular Lymphoma

What this Trial Is About

Researchers are evaluating the use of Axicabtagene Ciloleucel Injection to treat Chinese patients with relapsed or refractory follicular lymphoma FL. This is a Phase II, single-arm, multicenter study aiming to assess both the effectiveness and safety of this treatment in patients who have not responded to prior therapies, including anti-CD20 monoclonal antibody combined with an alkylating agent. The trial plans to enroll 30 subjects for this purpose. Participants will first undergo leukapheresis to collect mononuclear cells from their blood, targeting a volume of approximately 8-10 liters to obtain 5-10 billion cells. Before receiving the Axicabtagene Ciloleucel Injection, subjects will be given pre-treatment chemotherapy with cyclophosphamide and fludarabine intravenously on days -5, -4, and -3. On day 0, a single dose of CAR-T cells Axicabtagene Ciloleucel Injection will be infused intravenously, dosed by body weight with specific minimum and maximum limits. Throughout the study, participants will be closely monitored for treatment response and safety over up to 36 months. Researchers will evaluate outcomes such as the best objective response rate at 6 months, progression-free survival, complete and partial response rates, duration of response, and overall survival. Assessments will include clinical exams, laboratory tests, and imaging to track disease status and any side effects. The study is sponsored by The First Affiliated Hospital of Xiamen University and begins in February 2025.

Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma