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

StatusNot Yet Recruiting
PhasePhase 1/2
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07765524
Lead Sponsor Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Conditions
(from sponsor)		 Primary Light Chain (AL) Amyloidosis
Related terms Amyloidosis, Immunoglobulin Light-chain Amyloidosis
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov