NCT07765524Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- Aug 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.
- Diseases
- Amyloidosis
- NCT number
- NCT07765524
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From Aug 2026 to the primary completion date, Mar 2028
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
Other illness
- 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
Other
- 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;
Who the study is looking for
- 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);
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Sichuan Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Frist Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Frist Affiliated Hospital of Guangxi Medical university Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tongji Mecial college of HUST Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.