Evaluating SCTB35 for treating systemic lupus erythematosus

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 testing a new treatment called SCTB35 to see if it is safe and effective for people with systemic lupus erythematosus.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sinocelltech Ltd. (Industry-sponsored)
• Locations: 14 sites (Beijing and 13 other locations)
• Trial ID: NCT06841042 on ClinicalTrials.gov

What this trial studies

This multicenter Phase Ib/II clinical trial aims to assess the safety, tolerability, and efficacy of SCTB35 in patients diagnosed with systemic lupus erythematosus (SLE). The study includes dose-escalation and dose-expansion phases, where the escalation cohorts will help determine the maximum tolerated dose and the recommended phase II dose (RP2D). A Safety Review Committee will evaluate safety data and recommend appropriate dose levels for the expansion cohorts, which will further compare the efficacy and safety of SCTB35.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of systemic lupus erythematosus for at least 12 weeks and specific disease activity criteria.

Not a fit: Patients who do not meet the eligibility criteria or have not been stable on their current treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic lupus erythematosus.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in evaluating new treatments for systemic lupus erythematosus.

Eligibility criteria

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 elevated anti-dsDNA antibody levels;
4. Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening;
5. Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs

   1. Stable corticosteroid dose for ≥4 weeks prior to baseline;
   2. Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;
   3. Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;
6. 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;
7. Understanding of the study procedures and voluntary signing of the informed consent form.

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 or screening;
6. Clinically significant bleeding risk;
7. Abnormal laboratory results:

   1. AST or ALT \>2.5 x ULN;
   2. Total bilirubin \>1.5 x ULN;
   3. ANC \<1.5x10⁹/L;
   4. Platelets \<75x10⁹/L;
   5. Hemoglobin \<100g/L;
8. eGFR \<30 mL/min/1.73 m²;
9. Positive serum HCG;
10. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
11. Participants with recurrent, chronic, or other active infections as assessed by the investigator;
12. Severe or uncontrolled disease, which would prevent participation in the study;
13. Positive viral serology tests, including HIV, HCV, and HBV;
14. Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);
15. Any type of active infection except nail bed fungal infections;
16. Severe infections;
17. History of progressive multifocal leukoencephalopathy (PML);
18. Diagnosed with type 1 or type 2 diabetes with poor control;
19. Uncontrolled hypertension (systolic \>140 mmHg or diastolic \>90 mmHg);
20. History of malignancy within 5 years prior to baseline;
21. Alcohol abuse or drug misuse within 12 months prior to screening;
22. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;
23. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
24. Participants with mental disorders or poor compliance;
25. Severe lupus nephritis;
26. History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study;
27. Pregnant or breastfeeding;
28. Any other condition that the investigator deems unsuitable for participation in the study.

Where this trial is running

Beijing and 13 other locations

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Xuanwu Hospital, Capital Medical University — Beijing, China (Not_yet_recruiting)
• Jilin Provincial People's Hospital — Changchun, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Not_yet_recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Not_yet_recruiting)
• The First People's Hospital of Jiujiang City — Jiujiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, China (Not_yet_recruiting)
• Linfen Central Hospital — Linfen, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Not_yet_recruiting)
• Pingxiang People's Hospital — Pingxiang, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Not_yet_recruiting)
• Xinxiang Central Hospital — Xinxiang, China (Not_yet_recruiting)

Conditions System Lupus Erythematosus