Primary Light Chain (AL) Amyloidosis

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Review clinical trials related to Primary Light Chain (AL) Amyloidosis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 32
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd.Updated: Aug 14, 2026Locations: 11
Eligibility criteria

Voluntarily signed the informed consent form (ICF); [+7]

Presence of any clinically significant cardiovascular disease within 6 months pr... [+5]