A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus (NCT06694298) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
50 participantsStarted 2024-12-26
Plain-language summary
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age ≥18 years old, ≤70 years old;
* 2\. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
* 3\. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
* 4\. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
* 5\. SLEDAI-2K score≥7.
* 6\. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems
* 7\. PGA \> 1.0;
Exclusion Criteria:
* 1\. Severe lupus nephritis within 8 weeks before screening;
* 2\. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
* 3\. uncontrolled lupus crisis within 8 weeks before screening;
* 4\. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
* 5\. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
* 6\. complicated with other autoimmune diseases;
* 7\. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
* 8\. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
* 9\. participants who will undergo major surgery or invasive intervention w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
Timeframe: 28 days after infusion
2
recommended dose (RD)
Timeframe: 6 Months
3
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).