Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

About this trial

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)

Eligibility criteria

Qualifiers

Aged 18 to 75 years inclusive, either gender;

Absolute neutrophil count ≥ 1.0 × 10⁹/L, hemoglobin ≥ 60 g/L, platelet count ≥ 50 × 10⁹/L;

Hepatic function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN;

Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing

Treatment groups

18 Participants
are divided into 1 treatment group