A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

Sichuan Baili Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 84 人开始时间: 2025年6月4日最近更新: 2026年7月10日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Sichuan Baili Pharmaceutical Co., Ltd.
入组人数: 84
试验地点: 1
主要终点: Phase Ia: Dose limiting toxicity (DLT)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

This study is divided into Phase Ia and Phase Ib studies. The Phase Ia study adopts a single-arm design, while the Phase Ib study will be conducted on the basis of the Phase Ia study and features an open-label, randomized, active-controlled design, with belimumab as the control agent.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;
•No gender limit;
•Age: ≥18 years old and ≤75 years old;
•Life expectancy greater than 6 months;
•SLE was diagnosed according to the 2019 EULAR/ACR revised criteria;
•Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score &gt at screening; 7 points;
•A stable standard-of-care regimen was maintained for at least 30 days before the first dose;
•ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening;
•The presence of CD19+ B cells in the peripheral blood of the patient;
•The organ function level before the first administration met the requirements;
•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;
•Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

排除标准

•Severe lupus nephritis within 8 weeks before screening;
•She had uncontrolled lupus crisis within 8 weeks before screening and was not suitable for the study as assessed by the investigator;
•Active encephalopathy or psychosis within 6 months before screening;
•Primary diagnosis of different autoimmune or inflammatory diseases;
•B cell-depleting therapy within 6 months before initiation of GNC-038 treatment;
•Received CAR-T therapy within 6 months before GNC-038 treatment;
•Cytokine-targeting biologic agents used within 12 weeks before dose administration;
•Use of anti-tumor necrosis factor drugs within 8 weeks before administration;
•Use of any JAK inhibitor within 2 weeks before dosing;
•Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;
•Major organ transplantation history or hematopoietic stem cell/bone marrow transplantation;
•Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;
•A history of any cardiovascular disease described in the protocol within 6 months before screening;
•Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
•Prolonged QT interval at rest (QTcf > 450 msec in men or > 470 msec in women);
•A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;
•Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;
•Women who are pregnant or breastfeeding;
•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;
•Diagnosed with malignant tumor within 5 years before signing ICF;
•Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;
•History of splenectomy;
•Investigators considered a history of alcohol or drug abuse in the 12 months before screening;
•Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;
•A history of severe and/or disseminated viral infection;
•Active M. tuberculosis infection may be present.

研究组 & 干预措施

GNC-038

Experimental

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.

干预措施: GNC-038 (Drug)

结局指标

主要结局

Phase Ia: Dose limiting toxicity (DLT)

时间窗: Up to approximately 28 days

DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

Phase Ia: Maximum tolerated dose (MTD)

时间窗: Up to approximately 28 days

MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

Phase Ia: Treatment-Emergent Adverse Event (TEAE)