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 range18 Years – 75 Years
SexALL
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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;
✓. 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.
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
✕. 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.