Clinical trial for Systemic Lupus Erythematosus
Official title A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06857214
What this study is testing
What is GNC-038?
GNC-038 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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;
You likely can't join if
- 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;
See the full eligibility criteria
- people 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 \> 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 people of childbearing potential or male people 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...
- Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.