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
1 other identifier
interventional
32
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2026
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 11, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
August 14, 2026
August 1, 2026
1.6 years
August 11, 2026
August 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Within 28 days after FKC289 infusion
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Within 24 months after FKC289 infusion
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Within 24 months after FKC289 infusion
Secondary Outcomes (4)
Hematologic complete response rate (CRR)
Within 6 months,12 months, and 24 months after FKC289 infusion
Hematologic objective response rate (ORR)
Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Within 24 months after FKC289 infusion
Pharmacodynamics (PD)
Within 24 months after FKC289 infusion
Study Arms (1)
FKC289 injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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);
- 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;
- History of malignancy within 5 years prior to signing the ICF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The Frist Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510600, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700, China
The Frist Affiliated Hospital of Guangxi Medical university
Nanning, Guangxi, 530021, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Mecial college of HUST
Wuhan, Hubei, 430030, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
West China Hospital Sichuan Hospital
Chengdu, Sichuan, 610000, China
The Second Affiliated Hospital Zhejiang University school of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2026
First Posted
August 14, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 1, 2029
Last Updated
August 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share