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SCTC21C Combination Therapy for Newly Diagnosed Systemic Light-Chain Amyloidosis

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Study Aim

This phase 3 study aims to evaluate the percentage of newly diagnosed systemic light-chain amyloidosis patients who achieve a complete hematologic response when treated with the SCTC21C combination therapy.

What is being tested

SCTC21C

+ Bortezomib

+ Dexamethasone

Drug
Who is being recruted

Amyloidosis+1

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorSinocelltech Ltd.
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 8, 2026

Actual date on which the first participant was enrolled.

A clinical trial is currently underway to assess the safety and effectiveness of a drug called SCTC21C. This study focuses on patients newly diagnosed with a condition known as systemic light-chain amyloidosis. The purpose of this research is to find a better treatment approach for this condition. The current standard treatment involves a combination of drugs: Bortezomib, Cyclophosphamide, and Dexamethasone. This study aims to evaluate if adding SCTC21C to this mix improves the treatment outcomes. The potential benefits of this study could lead to enhanced care for patients with this specific condition. The study is divided into two parts, with each part having three stages: screening, treatment, and follow-up. During the treatment stage, participants receive either the standard treatment or the standard treatment plus SCTC21C. The safety of the treatment is monitored by tracking any side effects, changes in lab test results, vital signs, and physical examinations. The effectiveness of the treatment is measured by the percentage of participants who show a complete hematologic response, according to the International Amyloidosis Consensus Criteria. This response indicates how well the treatment is working to manage the disease.

Official TitleA 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
NCT07388602
Principal SponsorSinocelltech Ltd.
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisMetabolic DiseasesNutritional and Metabolic DiseasesProteostasis Deficiencies

Criteria

4 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking Union Medical College Hospital

Beijing, ChinaOpen Peking Union Medical College Hospital in Google Maps
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One Study Center