drugset / Trial / NCT05978661
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |