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 | Recruiting Phase 3 DMC

• 1 other identifier: SCTC21C-B301
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Complete Hematologic Response (CHR)

  Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria.

  Up to approximately 50 months after the First Participant In (FPI)

Secondary Outcomes (6)

• Major Organ Deterioration Progression-Free Survival (MOD-PFS)

  Up to approximately 50 months after the FPI

• Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months

  Month 6

• Duration of Complete Hematologic Response (CHR)

  Up to approximately 50 months after the FPI

• Hematologic Very Good Partial Response (VGPR) or Better Rate

  Up to approximately 50 months after the FPI

• Overall Survival (OS)

  Up to approximately 50 months after the FPI

Other Outcomes (1)

• PRO: EQ-5D-5L

  Up to approximately 50 months after the FPI

Study Arms (2)

SCTC21C + VCd (S-VCd)

EXPERIMENTAL

Drug: SCTC21C; Drug: Bortezomib; Drug: Dexamethasone; Drug: Cyclophosphamide

VCd

ACTIVE COMPARATOR

Drug: Bortezomib; Drug: Dexamethasone; Drug: Cyclophosphamide

Interventions

SCTC21C DRUG

Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous

SCTC21C + VCd (S-VCd)

Dexamethasone DRUG

Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

SCTC21C + VCd (S-VCd); VCd

Cyclophosphamide DRUG

Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

SCTC21C + VCd (S-VCd); VCd

Bortezomib DRUG

Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous

SCTC21C + VCd (S-VCd); VCd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Interventions

Bortezomib; Dexamethasone; Cyclophosphamide

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

CN (1)