Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing | Drug | Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (KN3601) will infused using dose-escalation strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy | up to 24 months after infusion |
| The overall response rate (ORR) | To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy | up to 24 months after infusion |
Not provided
Not provided
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;
Diagnosis of primary membranous nephropathy confirmed by renal biopsy pathology;
Meet the clinical criteria for high-risk or relapsed/refractory membranous nephropathy, defined as:
High-risk patients meeting any of the following:
For relapsed/refractory membranous nephropathy patients during screening: eGFR ≥ 45 mL/min/1.73 m².
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang He | Contact | +86-13588870088 | strong_he@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided