AmyloidosisPhase 3NCT07388602
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)
A Phase 3 study testing SCTC21C, Bortezomib and Dexamethasone in people with Amyloidosis, run by Sinocelltech Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- SCTC21C, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Yazhou Zhao, 13001958778, yuhuan_jiao@sinocelltech.com
About this study
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
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.
Read the detailed description
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).
- Conditions
- Amyloidosis
- Being tested
- SCTC21C, Bortezomib, Dexamethasone, Cyclophosphamide
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTC21CDrug
Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
BortezomibDrug
Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
DexamethasoneDrug
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
CyclophosphamideDrug
Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
| Study group | Role | What they receive |
|---|---|---|
| SCTC21C + VCd (S-VCd) | Experimental | Not described Receives: Drug: SCTC21C; Drug: Bortezomib; Drug: Dexamethasone; Drug: Cyclophosphamide |
| VCd | Active comparator | Not described Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 50 months after the First Participant In (FPI)
Secondary outcomes (6)
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first.
Measured: Up to approximately 50 months after the FPI
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria.
Measured: Month 6
Duration of Complete Hematologic Response (CHR)
Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased.
Measured: Up to approximately 50 months after the FPI
Hematologic Very Good Partial Response (VGPR) or Better Rate
Hematologic VGPR or Better Rate was defined as percentage of participants who achieved hematologic Complete response (CR) or VGPR.
Measured: Up to approximately 50 months after the FPI
Overall Survival (OS)
Overall survival (OS) was measured from the date of randomization to the date of the participant's death.
Measured: Up to approximately 50 months after the FPI
Adverse Events
Treatment-emergent adverse events/serious adverse events
Measured: Up to approximately 50 months after the FPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start8 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388602
- Sponsor's protocol ID
- SCTC21C-B301
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07388602
- Acronym / sponsor ID
- SCTC21C-B301
- Conditions
- Amyloidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTC21C + VCd (S-VCd) | Experimental | Drug: SCTC21C, Drug: Bortezomib, Drug: Dexamethasone, Drug: Cyclophosphamide |
| VCd | Active comparator | Drug: Bortezomib, Drug: Dexamethasone, Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTC21CPharmaceutical form: Solution for infusion； Route of administration: Subcutaneous | Drug | SCTC21C + VCd (S-VCd) |
| BortezomibPharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous | Drug | SCTC21C + VCd (S-VCd), VCd |
| DexamethasonePharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous | Drug | SCTC21C + VCd (S-VCd), VCd |
| CyclophosphamidePharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous | Drug | SCTC21C + VCd (S-VCd), VCd |
Primary outcome
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Time frame: Up to approximately 50 months after the First Participant In (FPI)
Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria.
6 secondary outcomes
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Time frame: Up to approximately 50 months after the FPI
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
Time frame: Month 6
Duration of Complete Hematologic Response (CHR)
Time frame: Up to approximately 50 months after the FPI
Hematologic Very Good Partial Response (VGPR) or Better Rate
Time frame: Up to approximately 50 months after the FPI
Overall Survival (OS)
Time frame: Up to approximately 50 months after the FPI
Adverse Events
Time frame: Up to approximately 50 months after the FPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCTC21C, Bortezomib and Dexamethasone in people with Amyloidosis, run by Sinocelltech Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Overall Complete Hematologic Response (CHR) (time frame: Up to approximately 50 months after the First Participant In (FPI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.