Actively Recruiting
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)
Led by Sinocelltech Ltd. · Updated on 2026-02-05
90
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of amyloidosis confirmed by immunohistochemistry and polarizing light microscopy or electron microscopy
- Measurable amyloid light-chain (AL) amyloidosis disease
- Involvement of one or more organs affected by AL amyloidosis according to consensus guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Age 18 years or older
You will not qualify if you...
- Prior therapy for AL amyloidosis
- Other types of amyloidosis
- Uncontrolled infections
- Significant conditions affecting safety or efficacy assessments, including cardiovascular, respiratory, endocrine/metabolic, immune, hepatic, gastrointestinal disorders, or malignant neoplasms deemed significant by the investigator
- Major surgery or significant trauma within 4 weeks before starting the investigational drug, or planned elective surgery during the study
- Received a live or attenuated vaccine within 30 days before first dose
- Female subjects currently breastfeeding
- Mental disorders, poor compliance, or other investigator-determined reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here