FKC289 for Primary AL Amyloidosis That Has Returned or Not Responded to Treatment
Tests FKC289 in adults whose AL amyloidosis returned or did not respond.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Chengdu, Guangzhou, Hangzhou, Jinan, Nanjing, Nanning, Shanghai, Wuhan, and Zhengzhou, ChinaSee the 11 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07765524, who can take part
Where in China
- Sichuan Provincial People's HospitalChengdu, ChinaNo longer taking part
- West China Hospital Sichuan HospitalChengdu, ChinaNo longer taking part
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- The Frist Affiliated Hospital of Jinan UniversityGuangzhou, ChinaNo longer taking part
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Qilu Hospital of Shandong UniversityJinan, ChinaNo longer taking part
- Jiangsu Province HospitalNanjing, ChinaNo longer taking part
- The Frist Affiliated Hospital of Guangxi Medical universityNanning, ChinaNo longer taking part
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
- Tongji Mecial college of HUSTWuhan, ChinaNo longer taking part
- Henan Cancer HospitalZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.
- Trial code
- NCT07765524
- Record updated
- 14 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Voluntarily signed the informed consent form (ICF); Aged between 18-75 years old (inclusive); Confirmed clinical diagnosis of primary light chain (AL) amyloidosis; Relapsed or refractory disease; dFLC ≥ 40 mg/L (based on central laboratory test results); ECOG performance status of 0 to 2; No active systemic infection within 2 weeks prior to leukapheresis; Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary).
Exclusion: Presence of any clinically significant cardiovascular disease within 6 months prior to screening; Clinically significant central nervous system (CNS) disease or pathological abnormality; History of solid organ transplantation (e.g., heart, lung, kidney, liver); History of malignancy within 5 years prior to signing the ICF; Presence of complete intestinal obstruction; Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.