Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT06826118
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axicabtagene Ciloleucel — 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

Study Details

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.

Key Dates

First listed
Feb 13, 2025
Start date
Feb 8, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axicabtagene Ciloleucel Injection
    The total blood volume circulated is recommended to be approximately 8-10 liters to obtain about (5-10)×10\^9 mononuclear cells. The collected sample will be packaged according to the study product manual and quickly transported to the cell preparation center for the preparation of Axicabtagene Ciloleucel Injection. Pre-treatment chemotherapy. Axicabtagene Ciloleucel Injection infusion.

Primary Outcome Measure

Best Objective Response Rate (bORR) at 6 months [ Time Frame: Up to 36 months ]

Central Contacts

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