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System Lupus ErythematosusPhase 1/2NCT06841042

A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

A Phase 1/2 study testing SCTB35 injection in people with System Lupus Erythematosus, run by Sinocelltech Ltd. at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
System Lupus Erythematosus
What is being tested?
SCTB35 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
14 sitesChina
Study dates
Feb 2025to Oct 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

  • Age 18-75 years；
  • Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria);
  • SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;
  • Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening;
  • Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs
  • Stable corticosteroid dose for ≥4 weeks prior to baseline;
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  • Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;
  • Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;
  • All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 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;
  • Other autoimmune diseases that may interfere with efficacy evaluation;
  • Catastrophic antiphospholipid syndrome;
  • Received treatments that may affect the drug's effect:
  • Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;
  • Clinically significant bleeding risk;
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  • Abnormal laboratory results:
  • AST or ALT >2.5 x ULN;
  • Total bilirubin >1.5 x ULN;
  • ANC <1.5x10⁹/L;
  • Platelets <75x10⁹/L;
  • Hemoglobin <100g/L;
  • eGFR <30 mL/min/1.73 m²;
  • Positive serum HCG;
  • Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
  • Participants with recurrent, chronic, or other active infections as assessed by the investigator;
  • Severe or uncontrolled disease, which would prevent participation in the study;
  • Positive viral serology tests, including HIV, HCV, and HBV;
  • Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);
  • Any type of active infection except nail bed fungal infections;
  • Severe infections;
  • History of progressive multifocal leukoencephalopathy (PML);
  • Diagnosed with type 1 or type 2 diabetes with poor control;
  • Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg);
  • History of malignancy within 5 years prior to baseline;
  • Alcohol abuse or drug misuse within 12 months prior to screening;
  • Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;
  • Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
  • Participants with mental disorders or poor compliance;
  • Severe lupus nephritis;
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

14 sites in 1 country

China14 sites, 14 recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing

    XiaoFeng Zeng M.D., 13501069845, xiaofeng.zeng@cstar.org.cn

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing

    Yi Zhao

    Not yet recruiting

  • Jilin Provincial People's Hospital

    Changchun

    Guoping Jiang

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Yang Li

    Not yet recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou

    Yashong Li

    Not yet recruiting

  • The First People's Hospital of Jiujiang City

    Jiujiang

    Ju Liu

    Not yet recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming

    Jian Xu

    Not yet recruiting

  • Linfen Central Hospital

    Linfen

    Shuhua Qiang

    Not yet recruiting

  • Mianyang Central Hospital

    Mianyang

    Jing Yang

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Rui Wu

    Not yet recruiting

  • Pingxiang People's Hospital

    Pingxiang

    Jiankang Hu

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan

    Liyun Zhang

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Guixiu Shi

    Not yet recruiting

  • Xinxiang Central Hospital

    Xinxiang

    Wenqiang Fan

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).

Read the detailed description

This study contains the dose-escalation and dose-expansion parts. The escalation cohorts will be enrolled to explore the maximum tolerated dose and recommended phase II dose (RP2D). A Safety Review Committee (SRC) will review the accumulated safety data and other available data, and make a recommendation to each dose level of SCTB35 in the escalation cohorts. The expansion cohorts will be initiated after the RP2D is confirmed, and to further compare the preliminary efficacy and safety of SCTB35 at appropriate dose levels recommended by SRC.

Being tested
SCTB35 injection
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.

  • SCTB35 injectionBiological

    SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTB35 will be applied for the dose-expansion cohorts.

Study groups in NCT06841042
Study groupRoleWhat they receive
Experimental: SCTB35ExperimentalSCTB35 will be administered every 21 days per treatment cycle.
Receives: Biological: SCTB35 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-escalation part： Incidence rate of adverse event (AE)

    To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)

    Measured: From first dose to the 24 weeks

  2. Dose-expansion part：SRI-4

    Percentage of subjects who achieved an SRI-4 response at 24 weeks；

    Measured: Up to Week 24

Secondary outcomes (7)

  1. Dose-escalation part： SLEDAI-2K

    Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.

    Measured: Up to week 12, 24

  2. Dose-escalation part： physician global assessment (PGA)

    Percentage of subjects with no worsening in PGA, where worsening is defined as a ≥0.3 point increase in PGA at 12 and 24 weeks.

    Measured: Up to week 12, 24

  3. Dose-escalation part：Immunogenicity；

    Serum anti-SCTB35 antibody and anti-SCTB35 antibody levels before and after administration

    Measured: From baseline to Week 24

  4. Dose-expansion part：SLEDAI-2K

    Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.

    Measured: Up to week 12, 24

  5. Dose-expansion part： BILAG

    Percentage of subjects with no new BILAG A or ≤1 new BILAG B at 12 and 24 weeks.

    Measured: Up to week 12, 24

  6. Dose-expansion part： PGA

    Percentage of subjects with no worsening in PGA at 12 and 24 weeks.

    Measured: Up to week 12, 24

  7. Dose-expansion part： SFI

    Time to first disease relapse

    Measured: Up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841042
Sponsor's protocol ID
SCTB35-X201
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCTB35 injection in people with System Lupus Erythematosus, run by Sinocelltech Ltd. at 14 sites 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 10 inclusion and 33 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 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?

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?

Dose-escalation part： Incidence rate of adverse event (AE) (time frame: From first dose to the 24 weeks). 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?

On the ClinicalTrials.gov record for NCT06841042.

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 21 Feb 2025.

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