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)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 \[28 days\] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include Overall Complete Hematologic Response (CHR)，objective response rate (ORR), Hematologic Very Good Partial Response (VGPR) or Better Rate, Overall Survival (OS).

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	SCTC21C	Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
DRUG	Bortezomib	Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
DRUG	Dexamethasone	Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
DRUG	Cyclophosphamide	Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China