FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.
China9 participantsStarted 2025-09-25
Plain-language summary
This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
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
. Voluntary participation in the clinical study, with the subject or their legally authorized representative fully understanding and providing written informed consent (ICF) for this study, and willingness to comply with and complete all trial procedures.
. Aged 18 to 70 years.
. ECOG performance status ≤ 2.
. Life expectancy of at least 12 weeks.
. Adequate venous access for apheresis and no other contraindications to blood cell separation.
. Laboratory parameters at screening must meet the following requirements, with no receipt of cell growth factors within 7 days (or 2 weeks for long-acting formulations) prior to the screening hematology assessment:
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.
. Cardiac ejection fraction ≥ 45%, no pericardial effusion (excluding minimal or physiological effusion) confirmed by echocardiography (ECHO), and no clinically significant findings on electrocardiogram (ECG).
. Baseline oxygen saturation \> 92% while breathing room air.
Exclusion criteria
. Active central nervous system (CNS) disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
. Presence or suspicion of fungal, bacterial (including but not limited to Mycobacterium tuberculosis), viral, or other infection that is uncontrolled or requires intravenous antifungal, antibacterial, or antiviral therapy; uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted.
. Hepatitis B (positive for hepatitis B surface antigen \[HBsAg\] with HBV DNA \> 1000 copies/mL), hepatitis C (positive for hepatitis C antibody), syphilis infection (positive for antibody), or human immunodeficiency virus (HIV) infection.
. Prior or concomitant medication:
. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrollment.
. History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Schwachman-Diamond syndrome, etc.
. History of lymphoproliferative disease or malignancy (except for basal cell carcinoma of the skin, in situ carcinoma of the breast/cervix, and other diseases that are disease-free and have not been treated within the past five years).
. Women of childbearing potential who are pregnant or breastfeeding.