NCT07765524

A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis

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레지스트리 요약

진행 상태: 모집 전 (NOT_YET_RECRUITING)
질환/조건: Primary Light Chain (AL) Amyloidosis
시험 유형: 중재 연구 (INTERVENTIONAL)
단계: Phase 1, Phase 2
목적: 치료
중재 유형: 약물
개입·치료: FKC289 infusion
Lead Sponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd. (산업계)

캐시 시각: 2026-08-15 01:34:24

ClinicalTrials.gov에서 보기

요약

This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D). And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects with hematologically best complete response (CR) within 6 months.

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