SCTC21C plus bortezomib, cyclophosphamide and dexamethasone for newly diagnosed systemic light-chain (AL) amyloidosis
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
PHASE3 · Sinocelltech Ltd. · NCT07388602
This trial tests whether adding SCTC21C to standard bortezomib‑cyclophosphamide‑dexamethasone (VCd) helps people with newly diagnosed AL (light‑chain) amyloidosis achieve better hematologic responses and outcomes.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sinocelltech Ltd. (industry) |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07388602 on ClinicalTrials.gov |
What this trial studies
The trial includes a Part 1 safety run‑in followed by a Part 2 randomized, controlled, open‑label, multicenter comparison of SCTC21C plus VCd versus VCd alone. Each part has screening (up to 28 days), a treatment period of repeating 28‑day cycles beginning at Cycle 1 Day 1 that continues until disease progression or unacceptable toxicity, and a post‑intervention follow‑up period. Safety is monitored through adverse events, lab tests, vital signs, physical exams and ECGs. Efficacy endpoints include complete hematologic response, overall response rates, very good partial response or better, and overall survival.
Who should consider this trial
Good fit: Adults with newly diagnosed AL amyloidosis who have measurable disease, at least one organ involved, ECOG performance status 0–2, and no prior therapy are the intended candidates.
Not a fit: Patients with other types of amyloidosis, prior systemic therapy for AL amyloidosis, uncontrolled infection, or clinically significant comorbidities that would interfere with safety or efficacy assessments are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding SCTC21C could increase complete hematologic response rates and potentially improve survival compared with VCd alone.
How similar studies have performed: Adding targeted antibodies to bortezomib‑based regimens (for example daratumumab plus CyBorD) has improved hematologic responses in AL amyloidosis in prior studies, but SCTC21C is a novel agent and its benefit is unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Prior therapy for AL amyloidosis; * Other amyloidosis; * 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 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. * Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyloidosis