NCT07423572
Not yet recruiting
Early 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)
The First Affiliated Hospital of Zhejiang Chinese Medical University1 site in 1 country18 target enrollmentStarted: February 28, 2026Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Incidence of Dose-Limiting Toxicity (DLT)
Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 75 years inclusive, either gender;
- •Adequate function of major organs as defined below:
- •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;
- •Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥ 50%;
- •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;
- •Diagnosis of primary membranous nephropathy confirmed by renal biopsy pathology;
- •Meet the clinical criteria for high-risk or relapsed/refractory membranous nephropathy, defined as:
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.
- •Subjects with psychiatric disorders and severe cognitive impairment.
- •Subjects who participated in other clinical trials within 6 months prior to enrollment.
Arms & Interventions
KN3601
Experimental
Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (KN3601) will infused using dose-escalation strategy.
Intervention: CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing (Drug)
Outcomes
Primary Outcomes
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: up to 24 months after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
The overall response rate (ORR)
Time Frame: up to 24 months after infusion
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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