RecruitingPhase 2NCT06826118

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

Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

30 participants

Start Date

Feb 8, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphoma Follicular Lymphoma Refractory Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy (a treatment where your own immune cells are reprogrammed to attack cancer), in people with relapsed or refractory large B-cell lymphoma (an aggressive blood cancer) who have had limited prior treatment. **You may be eligible if...** - You are 18 or older - You have large B-cell lymphoma that has relapsed or not responded to treatment - You have received 1–2 prior lines of therapy - You are in reasonably good physical condition (ECOG score 0–2) - Your organ function meets the required thresholds **You may NOT be eligible if...** - You have active central nervous system lymphoma - You have had a prior CAR-T cell therapy - You have active autoimmune disease requiring immunosuppression - You are pregnant or breastfeeding - You have serious active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAxicabtagene 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