NCT07388602 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)
| NCT ID | NCT07388602 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sinocelltech Ltd. |
| Condition | Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2026-01-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07388602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07388602 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT07388602 currently recruiting?
Yes, NCT07388602 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sinocelltech Ltd. to inquire about joining.
Where is the NCT07388602 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07388602 clinical trial?
NCT07388602 is sponsored by Sinocelltech Ltd.. The trial plans to enroll 90 participants.