A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus

NCT ID: NCT06857214

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2027-12-31

Brief Summary

This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.

Detailed Description

This study is divided into a phase Ia study and a phase Ib study. The phase Ib study has a randomized controlled design with a placebo control group. The phase Ia study has a single-arm design, and the phase Ib study will be carried out on the basis of the Phase Ia study.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GNC-038

Participants receive GNC-038 in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

GNC-038

Intervention Type: DRUG

Administration by intravenous infusion. Once a week (IV, QW), twice in total.

Placebo

The control group will be set up in phase Ib, participants will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The control group will be set up in phase Ib, and an appropriate dose will be selected based on phase Ia data.

Interventions

GNC-038

Administration by intravenous infusion. Once a week (IV, QW), twice in total.

Intervention Type: DRUG

Placebo

The control group will be set up in phase Ib, and an appropriate dose will be selected based on phase Ia data.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;

2. No gender limit;

3. Age: ≥18 years old and ≤75 years old;

4. Life expectancy greater than 6 months;

5. SLE was diagnosed according to the 2019 EULAR/ACR revised criteria;

6. Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score &gt at screening; 7 points;

7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose;

8. ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening;

9. The presence of CD19+ B cells in the peripheral blood of the patient;

10. The organ function level before the first administration met the requirements;

11. Female subjects of childbearing potential or male subjects with a fertile partner must use highly effective contraception from 7 days before the first dose until 24 weeks after the termination of treatment and should commit not to donate eggs (eggs, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;

12. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion Criteria

1. Severe lupus nephritis within 8 weeks before screening;

2. She had uncontrolled lupus crisis within 8 weeks before screening and was not suitable for the study as assessed by the investigator;

3. Active encephalopathy or psychosis within 6 months before screening;

4. Primary diagnosis of different autoimmune or inflammatory diseases;

5. B cell-depleting therapy within 6 months before initiation of GNC-038 treatment;

6. Received CAR-T therapy within 6 months before GNC-038 treatment;

7. Cytokine-targeting biologic agents used within 12 weeks before dose administration;

8. Use of anti-tumor necrosis factor drugs within 8 weeks before administration;

9. Use of any JAK inhibitor within 2 weeks before dosing;

10. Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;

11. Major organ transplantation history or hematopoietic stem cell/bone marrow transplantation;

12. Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;

13. A history of any cardiovascular disease described in the protocol within 6 months before screening;

14. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);

15. Prolonged QT interval at rest (QTcf > 450 msec in men or > 470 msec in women);

16. A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;

17. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;

18. Women who are pregnant or breastfeeding;

19. Have a history or evidence of suicidal thoughts within 6 months before signing ICF, which is considered by the researcher to be a significant risk of suicide;

20. Diagnosed with malignant tumor within 5 years before signing ICF;

21. Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;

22. History of splenectomy;

23. Investigators considered a history of alcohol or drug abuse in the 12 months before screening;

24. Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;

25. A history of severe and/or disseminated viral infection;

26. Active M. tuberculosis infection may be present.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Shuang Ye

Role: primary

Other Identifiers

GNC-038-106

Identifier Type: -

Identifier Source: org_study_id