A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus (NCT06530849) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
China20 participantsStarted 2024-08-22
Plain-language summary
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
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
. Voluntarily sign the ICF;
. Males or females, aged 18-70 years old (inclusive);
. Must be able and willing to comply with the study visit schedule and other protocol requirements;
. Presence of CD19+B cells in the peripheral blood;
. Diagnosed with SLE and meeting the 2019 EULAR/ACR classification criteria for SLE;
. Used standard SLE treatment regimens and at least a biological agent for more than 6 months but did not meet the LLDAS criteria
. SLEDAI-2000 scores ≥8 during the screening period. If the scores for low complement and/or anti-ds-DNA antibody are available, the SLEDAI-2000 scores for clinical symptoms (except low complement and/or anti-ds-DNA antibody) should be NLT 4;
. Positive serological test results of autoantibodies: Positive results of antinuclear antibody (ANA) and/or anti-ds-DNA antibody and/or anti-Sm antibody, with critical values not acceptable;
Exclusion criteria
. Receipt of CD19 and/or BCMA-targeted therapies or CAR T-cell therapies for any targets in the past;
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.
1Since this is a Phase 1/2 trial for GC012F injection, what does that mean for how much is currently known about its safety and whether it actually works for refractory lupus — and how does that uncertainty compare to other options I might have?
2The trial is measuring something called 'Dose-Limiting Toxicity' as a primary outcome, which suggests they're still figuring out safe dosing — what kinds of side effects have been reported so far, and how serious could they be?
3Since the study is no longer actively recruiting, is there any chance I could still be considered for enrollment, or are there similar CAR-T or targeted cell therapy trials for refractory lupus that I should look into instead?
4The trial is specifically for 'refractory' systemic lupus erythematosus — based on my treatment history, do you think I would even meet that definition, and are there any standard treatments I haven't yet tried that might be worth attempting first?
5The trial uses something called the SRI-4 response rate to measure whether the treatment is helping — can you explain what that means in practice for day-to-day symptoms, and is that a meaningful measure of improvement for someone with my specific type of lupus?
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.
. Receipt of CD20-targeted drug therapy within 6 months prior to screening;
. Receipt of immunosuppressants or prednisone \>15 mg/d or equivalent doses of other glucocorticoids within 1 week before the apheresis;
. Presence of any renal disorders: serious lupus nephritis (serum creatinine \>2.5 mg/dL or 221 μmol/L), or active nephritis requiring treatments with drugs forbidden in this protocol, or any needs for hemodialysis within 8 weeks prior to apheresis;
. Presence of any serious heart diseases as follows:
. Congestive heart failure (New York Heart Association (NYHA) Class III or IV);
. Myocardial infarction or receipt of coronary artery bypass grafting (CABG) within 6 months prior to screening;
. Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \>480 ms during the screening;