SCTC21C Added to Standard Drugs for Newly Diagnosed Light-Chain Amyloidosis
Tests adding SCTC21C to standard drugs in adults newly diagnosed with light-chain amyloidosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
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
- Sinocelltech Ltd.
- Trial code
- NCT07388602
- Record updated
- 5 February 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.Read full original descriptionShow less
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Inclusion: Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens or characteristic electron microscopy appearance; Measurable disease of amyloid light-chain (AL) amyloidosis; One or more organs impacted by AL amyloidosis according to consensus guidelines; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
Exclusion: Prior therapy for AL amyloidosis; Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period; Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding; Uncontrolled infection; Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator; Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators; Other amyloidosis.