Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Trea… (NCT07423572) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
China18 participantsStarted 2026-02-28
Plain-language summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
Who can participate
Age range
18 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
. Aged 18 to 75 years inclusive, either gender;
. Adequate function of major organs as defined below:
. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must use a medically acceptable contraceptive method or practice abstinence during study treatment and for at least 6 months after the end of treatment.Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be breastfeeding;
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
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: up to 24 months after infusion
2
The overall response rate (ORR)
Timeframe: up to 24 months after infusion
Trial details
NCT IDNCT07423572
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University
. Voluntarily agree to participate in this clinical study, provide written informed consent, demonstrate good compliance, and be willing to comply with follow-up procedures;
Exclusion criteria
. Subjects with known allergic reaction, hypersensitivity, intolerance, or contraindication to CD19/BCMA universal CAR-T or any components of the study drugs (including fludarabine, cyclophosphamide, and tocilizumab), or a history of severe allergic reaction in the past.
. Presence or suspicion of uncontrolled or treatable fungal, bacterial, viral, or other infections.
. Central nervous system diseases caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
. Subjects with severe cardiac diseases, such as angina pectoris, myocardial infarction, heart failure, arrhythmia, etc.
. Subjects with congenital immunoglobulin deficiency.
. Subjects with other malignant tumors (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder, or breast with disease-free survival \> 5 years).
. Subjects with end-stage renal failure.
. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA titer above the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with positive syphilis test.