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RECRUITING
NCT06826118
PHASE2

Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma

Sponsor: The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-08

Completion Date

2026-12-31

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

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

Locations (1)

Bing Xu

Xiamen, Fujian, China