BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease (NCT07729995) | Clinical Trial Compass
Not Yet RecruitingPhase 1
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
United States94 participantsStarted 2026-10
Plain-language summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.
Who can participate
Age range
16 Years – 75 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
. Male or female 16-75 years of age, inclusive.
. For participants with:
. Stable doses of corticosteroids for at least 4 weeks and other immunosuppressives for 8 weeks.
. Adequate organ function as defined by each of the following:
. Creatinine clearance more than or equal to 45 ml/min calculated per the 2021 CKD-EPI Creatinine Equation
. Participants must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.
. Adequate pulmonary function with pulse oximetry ≥92% on room air.
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
To evaluate the Incidence and Severity of Treatment-Emergent Adverse Events (Safety) of LMY-922 in Patients ≥16 Years of Age with Refractory Autoimmune Disease
Timeframe: 24 Months
2
To determine the recommended Phase II dose of LMY-922 based on Incidence of dose limiting toxicities in patients with refractory autoimmune disease.
. Total Bilirubin \< 1.5× the institutional upper limit of normal (except in participants with Gilbert's syndrome).
Exclusion criteria
. Significant disease-related complications
. Active thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA)
. Current or prior malignancy, unless the malignancy was treated with curative intent and the participant has no known active malignant disease present for ≥ 5 years prior to enrollment.
. Symptomatic congestive heart failure.
. Renal failure requiring regular dialysis.
. Uncontrolled pulmonary disease.
. Ongoing infection, whether controlled or uncontrolled.
. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.