NCT05978661

FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

A Single-Center Exploratory Study to Evaluate the Safety and Efficacy of FKC288 in Subjects With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nanjing University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The "BOIN" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed/refractory systemic Light Chain (AL) amyloidosis.

Detailed description

A leukapheresis procedure will be performed to manufacture FKC288 chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of FKC288 at 0.1, 0.3, 1.0, or 3.0x 10\^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after FKC288 infusion.

Conditions

• Light Chain Amyloidosis

Interventions

Type	Name	Description
DRUG	FKC288	Administration of FKC288 Four dose groups of 0.1×10\^6 CAR-T/kg, 0.3×10\^6 CAR-T/kg, 1.0×10\^6 CAR-T/kg, and 3.0×10\^6 CAR-T/kg FKC288 are designed in this study. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT.

Timeline

• Start date: 2023-08-29
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-08-07
• Last updated: 2023-11-15

Locations

1 site across 1 country: China