Actively Recruiting
A Phase 3 Randomized Open-label Multicenter Study Evaluating SCTC21C with Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone Alone in Newly Diagnosed Systemic Light-Chain Amyloidosis
Led by Sinocelltech Ltd. · Updated on 2026-02-05
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SCTC21C combined with cyclophosphamide, bortezomib, and dexamethasone compared to the combination without SCTC21C in adults newly diagnosed with amyloid light-chain (AL) amyloidosis. This Phase 3 study aims to better understand treatment responses and survival outcomes in this condition. The study is sponsored by Sinocelltech Ltd. and involves multiple centers. The study includes two parts: Part 1 focuses on safety, and Part 2 is a randomized, controlled, open-label trial. Both parts have three stages: screening (up to 28 days before treatment), treatment (starting with Cycle 1, Day 1, continuing until disease progression or unacceptable side effects), and follow-up after treatment. Participants receive either SCTC21C plus bortezomib, cyclophosphamide, and dexamethasone or just the latter three drugs. SCTC21C and bortezomib are given by subcutaneous injection, while dexamethasone and cyclophosphamide are given orally or intravenously. Participants will attend regular visits for safety checks including physical exams, vital signs, laboratory tests, electrocardiograms, and monitoring for side effects. Researchers will measure the overall complete hematologic response, response rates, progression-free survival, and overall survival up to about 50 months after the first participant starts treatment. The study assesses adverse events and the duration of response to the therapies. The total participation time varies depending on treatment response and safety.
CONDITIONS
Brief 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 specific tissue staining or electron microscopy
- Measurable amyloid light-chain (AL) amyloidosis disease
- One or more organs affected by AL amyloidosis according to guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adults aged 18 years or older
You will not qualify if you...
- Prior therapy for AL amyloidosis
- Diagnosis of other types of amyloidosis
- Uncontrolled infection
- Significant health conditions affecting safety or study assessments, including cardiovascular, respiratory, endocrine/metabolic, immune, liver, gastrointestinal issues, or malignant tumors
- Major surgery or significant trauma within 4 weeks before study drug use or planned elective surgery during the trial
- Receipt of live or attenuated vaccine within 30 days before first dose
- Currently breastfeeding if female
- Mental disorders, poor compliance, or other factors making participation unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Cycle 1 Day 1 (28-day cycles) until disease progression or unacceptable toxicity
Participants receive SCTC21C in combination with Bortezomib, Cyclophosphamide, and Dexamethasone or Bortezomib, Cyclophosphamide, and Dexamethasone alone. Treatment continues until disease progression or unacceptable toxicity occurs.
Visits occur according to treatment cycles; exact schedule depends on treatment plan
Duration - Up to approximately 50 months after first participant in
Participants are monitored after treatment ends to assess safety and efficacy outcomes including hematologic response and overall survival.
Periodic follow-up visits over the monitoring period
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
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