Systemic Lupus Erythematosus (SLE)Phase 1/2NCT07538154
A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus
A Phase 1/2 study testing SCTC21C in people with Systemic Lupus Erythematosus (SLE), run by Sinocelltech Ltd..
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- SCTC21C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2028
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
- SELENA-SLEDAI ≥8 at screening;
- Positive immunological markers within 12 months prior to baseline;
- Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;
- All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug
- Understanding of the study procedures and voluntary signing of the informed consent form
Who cannot join
- Severe active or unstable lupus-related neuropsychiatric disorders;
- Combined with active infections, malignant tumors, or other autoimmune diseases;
- Catastrophic antiphospholipid syndrome;
- severe lupus nephritis;
- Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;
- Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
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- Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;
- Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;
- In accordance with the protocol requirements, participants with abnormal laboratory test results;
- Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;
- participants with a history of tuberculosis or latent tuberculosis infection;
- Diagnosed with type 1 or type 2 diabetes with poor control;
- Uncontrolled hypertension;
- Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;
- Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
- History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study;
- Pregnant or breastfeeding;
- Any other condition that the investigator deems unsuitable for participation in the study
About this study
Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus
Read the detailed description
This study contains phase Ib and phase II studies. In phase Ib study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recomended dose of SCTC21C for the randomized dose optimation-stage. In phase 2 study, 2 dose levels will be uased. A total of 120 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- SCTC21C
- Keywords
- SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTC21CBiological
SCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts
| Study group | Role | What they receive |
|---|---|---|
| experimental: SCTC21C | Experimental | SCTC21C will be administered to participants for about 24 weeks Receives: Biological: SCTC21C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: safety and tolerability of SCTC21C
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)
Measured: From first dose to Week 48
Phase II: efficacy of SCTC21C
Percentage of participants who achiened an mSRI-4 response at W24
Measured: Up to Week 24
Secondary outcomes (6)
dose escalation part#SRI4/5/6/7/8
percentage of participants who achieved SRI4/5/6/7/8 response at specified time
Measured: up to Week 48
Dose- escalation # mSRI4/5/6/7/8
percentage of participants who achieved mSRI4/5/6/7/8 response at specified time
Measured: up to Week 48
Dose-escalation part # BILAG
The BILAG improvement rate among participants with baseline BILAG score of A or B at specified time
Measured: up to Week 48
Dose-escalation part # SLE flare
Time to first SLE flare
Measured: Up to Week 48
Dose-escalation part # immunogenicity
Serum anti-SCTC21C antibody and anti-SCTC21C neutralization antibody levels
Measured: up to Week 48
Dose-escalation part # SCTC21C
Serum SCTC21C levels at specified time
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 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
- NCT07538154
- Sponsor's protocol ID
- SCTC21C-C201
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07538154
- Acronym / sponsor ID
- SCTC21C-C201
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- SLE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Apr 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 safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus
Detailed description
This study contains phase Ib and phase II studies. In phase Ib study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recomended dose of SCTC21C for the randomized dose optimation-stage. In phase 2 study, 2 dose levels will be uased. A total of 120 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental: SCTC21C | Experimental | Biological: SCTC21CSCTC21C will be administered to participants for about 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years;
- Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
- SELENA-SLEDAI ≥8 at screening;
- Positive immunological markers within 12 months prior to baseline;
- Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;
Key exclusion criteria (18 listed)
- Severe active or unstable lupus-related neuropsychiatric disorders;
- Combined with active infections, malignant tumors, or other autoimmune diseases;
- Catastrophic antiphospholipid syndrome;
- severe lupus nephritis;
- Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening 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 |
|---|---|---|
| SCTC21CSCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts | Biological | experimental: SCTC21C |
Primary outcome
Phase 1: safety and tolerability of SCTC21C
Time frame: From first dose to Week 48
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)
Phase II: efficacy of SCTC21C
Time frame: Up to Week 24
Percentage of participants who achiened an mSRI-4 response at W24
6 secondary outcomes
dose escalation part#SRI4/5/6/7/8
Time frame: up to Week 48
Dose- escalation # mSRI4/5/6/7/8
Time frame: up to Week 48
Dose-escalation part # BILAG
Time frame: up to Week 48
Dose-escalation part # SLE flare
Time frame: Up to Week 48
Dose-escalation part # immunogenicity
Time frame: up to Week 48
Dose-escalation part # SCTC21C
Time frame: up to Week 48
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 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCTC21C in people with Systemic Lupus Erythematosus (SLE), run by Sinocelltech Ltd..
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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: safety and tolerability of SCTC21C (time frame: From first dose to Week 48). The study lists 2 primary outcomes in all. 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 20 Apr 2026.