Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
NCT06826118 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-02-13
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.
Conditions
- Lymphoma
- Follicular Lymphoma
- Refractory Lymphoma
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
The First Affiliated Hospital of Xiamen University
lead OTHER
Principal Investigators
-
Bing Xu · The First Aiffiliated hosptical of xiamen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-08
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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