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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)

NCT07388602 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Amyloidosis

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

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07388602 on ClinicalTrials.gov