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

Study Overview

• Status: Recruiting
• Conditions: System Lupus Erythematosus
• Intervention / Treatment: Biological: SCTB35 injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Contact: XiaoFeng Zeng M.D.; Phone Number: 13501069845; Email: xiaofeng.zeng@cstar.org.cn
  • Beijing, China
    • Not yet recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Yi Zhao
  • Changchun, China
    • Not yet recruiting
    • Jilin Provincial People's Hospital
    • Contact: Guoping Jiang
  • Guangzhou, China
    • Not yet recruiting
    • Guangdong Provincial People's Hospital
    • Contact: Yang Li
  • Hangzhou, China
    • Not yet recruiting
    • Zhejiang Provincial People's Hospital
    • Contact: Yashong Li
  • Jiujiang, China
    • Not yet recruiting
    • The First People's Hospital of Jiujiang City
    • Contact: Ju Liu
  • Kunming, China
    • Not yet recruiting
    • The First Affiliated Hospital of Kunming Medical University
    • Contact: Jian Xu
  • Linfen, China
    • Not yet recruiting
    • Linfen Central Hospital
    • Contact: Shuhua Qiang
  • Mianyang, China
    • Not yet recruiting
    • Mianyang Central Hospital
    • Contact: Jing Yang
  • Nanchang, China
    • Not yet recruiting
    • The First Affiliated Hospital of Nanchang University
    • Contact: Rui Wu
  • Pingxiang, China
    • Not yet recruiting
    • Pingxiang People's Hospital
    • Contact: Jiankang Hu
  • Taiyuan, China
    • Not yet recruiting
    • Shanxi Bethune Hospital
    • Contact: Liyun Zhang
  • Xiamen, China
    • Not yet recruiting
    • The First Affiliated Hospital of Xiamen University
    • Contact: Guixiu Shi
  • Xinxiang, China
    • Not yet recruiting
    • Xinxiang Central Hospital
    • Contact: Wenqiang Fan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: SCTB35; SCTB35 will be administered every 21 days per treatment cycle.	Biological: SCTB35 injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From first dose to the 24 weeks
Dose-expansion part：SRI-4	Percentage of subjects who achieved an SRI-4 response at 24 weeks；	Up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-escalation part： SLEDAI-2K	Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.	Up to week 12, 24
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.	Up to week 12, 24
Dose-escalation part：Immunogenicity；	Serum anti-SCTB35 antibody and anti-SCTB35 antibody levels before and after administration	From baseline to Week 24
Dose-expansion part：SLEDAI-2K	Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.	Up to week 12, 24
Dose-expansion part： BILAG	Percentage of subjects with no new BILAG A or ≤1 new BILAG B at 12 and 24 weeks.	Up to week 12, 24
Dose-expansion part： PGA	Percentage of subjects with no worsening in PGA at 12 and 24 weeks.	Up to week 12, 24
Dose-expansion part： SFI	Time to first disease relapse	Up to week 52

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SCTB35-X201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No