NCT06826118

Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma

A Single-Arm, Multicenter, Prospective, Exploratory Clinical Study of Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective collection of data on the treatment of Chinese patients with relapsed/refractory follicular lymphoma (FL) using Axicabtagene Ciloleucel Injection, and evaluation of the efficacy and safety of Axicabtagene Ciloleucel Injection in this treatment.

Detailed description

This study is a single-arm, multicenter, prospective Phase II clinical trial, planning to enroll 30 Chinese subjects with relapsed/refractory follicular lymphoma (R/R FL) who will receive Axicabtagene Ciloleucel Injection. The study aims to assess the efficacy and safety of Axicabtagene Ciloleucel Injection in treating Chinese patients with R/R FL.

Conditions

• Lymphoma
• Follicular Lymphoma
• Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	Axicabtagene Ciloleucel	Pre-treatment chemotherapy: Cyclophosphamide 500 mg/m² and Fludarabine 30 mg/m² will be administered intravenously on Days -5, -4, and -3 (with the day of Axicabtagene Ciloleucel Injection infusion being Day 0). Axicabtagene Ciloleucel Injection infusion: A single dose of autologous T cells transduced with chimeric antigen receptor (CAR) in the form of Axicabtagene Ciloleucel Injection will be administered to the subject intravenously. The target dose is 2.0×10\^6 anti-CD19 CAR-T cells/kg body weight. The minimum dose that can be used is 1.5×10\^6 anti-CD19 CAR-T cells/kg body weight. For subjects with a body weight of ≥100 kg, the maximum total dose is 2.0×10\^8 anti-CD19 CAR-T cells

Timeline

• Start date: 2025-02-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: China