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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Registry fields

Overall status: NOT_YET_RECRUITING
Conditions: Primary Light Chain (AL) Amyloidosis
Study type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary purpose: TREATMENT
Intervention type: DRUG
Interventions: FKC289 infusion
Lead sponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd. (INDUSTRY)

Cached at: 2026-08-15 01:34:24

View on ClinicalTrials.gov

Brief summary

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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