A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

Last updated: February 18, 2025
Sponsor: Sinocelltech Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

SCTB35 injection

Clinical Study ID

NCT06841042
SCTB35-X201
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years;

  2. Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria);

  3. SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevatedanti-dsDNA antibody levels;

  4. Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies withinthe last 12 months or at screening;

  5. Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids,antimalarials, or conventional immunosuppressive drugs

  6. Stable corticosteroid dose for ≥4 weeks prior to baseline;

  7. Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;

  8. Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;

  9. All male participants or females of reproductive potential must agree to usereliable contraception with their partner from signing the ICF through 6 monthsafter the last dose of the study drug;

  10. Understanding of the study procedures and voluntary signing of the informed consentform.

Exclusion

Exclusion Criteria:

  1. Severe active or unstable lupus-related neuropsychiatric disorders;

  2. Other autoimmune diseases that may interfere with efficacy evaluation;

  3. Catastrophic antiphospholipid syndrome;

  4. Received treatments that may affect the drug's effect:

  5. Received live vaccines or attenuated vaccines within 28 days prior to baseline orscreening;

  6. Clinically significant bleeding risk;

  7. Abnormal laboratory results:

  8. AST or ALT >2.5 x ULN;

  9. Total bilirubin >1.5 x ULN;

  10. ANC <1.5x10⁹/L;

  11. Platelets <75x10⁹/L;

  12. Hemoglobin <100g/L;

  13. eGFR <30 mL/min/1.73 m²;

  14. Positive serum HCG;

  15. Received any investigational treatment within 30 days prior to baseline or within 5half-lives of the investigational drug (whichever is longer);

  16. Participants with recurrent, chronic, or other active infections as assessed by theinvestigator;

  17. Severe or uncontrolled disease, which would prevent participation in the study;

  18. Positive viral serology tests, including HIV, HCV, and HBV;

  19. Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);

  20. Any type of active infection except nail bed fungal infections;

  21. Severe infections;

  22. History of progressive multifocal leukoencephalopathy (PML);

  23. Diagnosed with type 1 or type 2 diabetes with poor control;

  24. Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg);

  25. History of malignancy within 5 years prior to baseline;

  26. Alcohol abuse or drug misuse within 12 months prior to screening;

  27. Intolerance to the study drug or contraindications, including a history of severeallergic reactions to monoclonal antibodies or any component of SCTB35 injection;

  28. Required hospitalization for major surgery within 4 weeks prior to screening orwithin 12 weeks post-study drug administration;

  29. Participants with mental disorders or poor compliance;

  30. Severe lupus nephritis;

  31. History of solid organ or hematopoietic stem cell/bone marrow transplant, orexpected to undergo transplant surgery during the study;

  32. Pregnant or breastfeeding;

  33. Any other condition that the investigator deems unsuitable for participation in thestudy.

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: SCTB35 injection
Phase: 1/2
Study Start date:
February 01, 2025
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

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

    Beijing,
    China

    Active - Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Jilin Provincial People's Hospital

    Changchun,
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Site Not Available

  • The First People's Hospital of Jiujiang City

    Jiujiang,
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming,
    China

    Site Not Available

  • Linfen Central Hospital

    Linfen,
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang,
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan,
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen,
    China

    Site Not Available

  • Xinxiang Central Hospital

    Xinxiang,
    China

    Site Not Available

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