A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

Recruiting now · Phase 1/Phase 2

Conditions studied: System Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT06841042

Run by

Sinocelltech Ltd.

People needed

168

Starts

2025-02-01

Expected to finish

2028-10-01

Last updated by the study team

2025-02-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• 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.

You may not qualify if…

• 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;
• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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