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RECRUITING
NCT07388602
PHASE3

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)

Sponsor: Sinocelltech Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-01-08

Completion Date

2028-12

Last Updated

2026-02-05

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China