BCMA-CD19 cCAR T for the Treatment of Refractory Lupus (NCT07328581) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
BCMA-CD19 cCAR T for the Treatment of Refractory Lupus
20 participantsStarted 2026-01
Plain-language summary
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15/IL15sushi cCAR T cells in patients with relapsed and/or refractory SLE, with or without Lupus Nephritis.
Who can participate
Age range
16 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
. Age 16-70 years at the time of signing the informed consent
. Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months.
. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody
. Inadequate response to 2 prior standard of care therapies, used for at least three months
. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening
. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V)6.
Exclusion criteria
. Any acute, severe lupus related flare that needs immediate treatment
. History of antiphospholipid syndrome with thromboembolic event within 12 months
. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.
. Has drug-induced SLE.
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
Number of Adverse Events after ICG318 infusion
Timeframe: Starting day 0 and up to 1 year after ICG318 infusion.
2
DORIS remission rate
Timeframe: Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.