drugset / Trial / NCT05978661

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

NCT05978661 ↗

Phase 1 Unknown 12 enrolled Nanjing University School of Medicine
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-29
Primary completion
2025-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject FKC288 Cell therapy 100000 cells/kg —
Subject FKC288 Cell therapy 300000 cells/kg —
Subject FKC288 Cell therapy 1e+06 cells/kg —
Subject FKC288 Cell therapy 3e+06 cells/kg —

Indications