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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
Sponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd.
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-08
Completion Date
2029-09
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
FKC289 infusion
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
Locations (11)
The Frist Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Frist Affiliated Hospital of Guangxi Medical university
Nanning, Guangxi, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Mecial college of HUST
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital Sichuan Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University school of Medicine
Hangzhou, Zhejiang, China