ClinicalTrials.gov record 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)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 3 randomized, open-label study compares SCTC21C added to bortezomib, cyclophosphamide, and dexamethasone (VCd) versus VCd alone in people with newly diagnosed systemic light‑chain (AL) amyloidosis. The study has a safety run-in (Part 1) followed by a randomized controlled phase (Part 2). Treatment is given in 28‑day cycles and continues until disease progression or unacceptable toxicity, with follow-up after treatment. Key measures include complete hematologic response, organ outcomes, survival, and safety.

What it is studying. The study tests adding SCTC21C to the standard VCd drug combination and compares that with VCd alone to see effects on blood (hematologic) response, organ deterioration, survival, and safety.

What the researchers hope to learn. Scientifically, the study aims to evaluate the safety and efficacy of SCTC21C added to VCd by measuring overall complete hematologic response rate (primary) and secondary outcomes including major organ deterioration–free progression, CHR at 6 months, duration of CHR, hematologic VGPR or better rate, overall survival, and adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SCTC21C
  • Bortezomib
  • Dexamethasone
  • Cyclophosphamide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After a screening period of up to 28 days, participants are randomly assigned in an open‑label study to receive either SCTC21C plus bortezomib, cyclophosphamide, and dexamethasone (S‑VCd) or bortezomib, cyclophosphamide, and dexamethasone alone (VCd). Treatment is given in 28‑day cycles (Cycle 1 Day 1 is the start) and continues until disease progression or unacceptable toxicity. Participants will receive study drugs by subcutaneous injection and/or by oral or intravenous dosing as described in the trial, and will have regular safety and efficacy checks including blood tests, vital signs, physical exams, and electrocardiograms while adverse events are monitored. The study includes an initial safety run‑in phase (Part 1), a randomized treatment phase (Part 2), and a follow‑up period after treatment ends.

How the study is structured. Participants enter a short screening period (up to 28 days). Part 1 is a safety run-in. Part 2 is randomized and open-label: participants are randomly assigned to one of two parallel groups — SCTC21C plus VCd or VCd alone. Treatments are given in 28‑day cycles starting at Cycle 1 Day 1 and continue until disease progression or unacceptable toxicity. The study tracks responses, organ outcomes, and adverse events, then follows participants after stopping treatment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 8, 2026
Primary completion
December 2027 (estimated)
Study completion
December 2028 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Feb 5, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Sinocelltech Ltd.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Prior therapy
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
investigational drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
screening period
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
treatment-emergent adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
Very Good Partial Response
A response category used in some blood conditions meaning the disease marker has fallen a great deal but not disappeared. The exact definition depends on the condition and the study.
Overall Survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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