Refractory Idiopathic Membranous NephropathyEarly Phase 1NCT07423572
Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
A Early Phase 1 study testing CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing in people with Refractory Idiopathic Membranous Nephropathy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Idiopathic Membranous Nephropathy
- What is being tested?
- CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 28 Sep 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
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- 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:
- Estimated glomerular filtration rate (eGFR, CKD-EPI equation) < 60 mL/min/1.73 m², and/or urinary protein > 8 g/day for ≥ 6 months;
- Normal eGFR, urinary protein > 3.5 g/day despite ACEI/ARB treatment for 6 months with < 50% reduction in proteinuria, plus serum albumin < 25 g/L or anti-PLA2R antibody (aPLA2R) > 50 RU/mL; Refractory membranous nephropathy: inadequate response or resistance to prior immunosuppressive therapy (including corticosteroids and/or cytotoxic agents, immunosuppressants and/or biologics), defined as persistent urinary protein ≥ 3.5 g/day with < 50% reduction from baseline; Relapsed membranous nephropathy: recurrence (24-hour urinary protein ≥ 3.5 g) after achieving complete or partial remission (CR/PR) following treatment;
- For relapsed/refractory membranous nephropathy patients during screening: eGFR ≥ 45 mL/min/1.73 m².
Who cannot join
- 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).
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- 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.
- Pregnant or lactating females, or females intending to become pregnant during the study.
- Subjects with hypertension or diabetes mellitus that cannot be controlled by medication.
- Subjects for whom the investigator considers there are other reasons for ineligibility.
- Secondary membranous nephropathy (e.g., associated with hepatitis B, systemic lupus erythematosus, drug-related, malignancy-related, etc.), or concurrent renal disease confirmed by renal biopsy.
- Type 1 or type 2 diabetes mellitus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
Qiang He, Dr, +86-13588870088, strong_he@163.com
About this study
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)
- Being tested
- CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 24 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423572
- Sponsor's protocol ID
- 2026-KLS-021-02
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
- ClinicalTrials.gov ID
- NCT07423572
- Acronym / sponsor ID
- 2026-KLS-021-02
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN3601 | Experimental | Drug: CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusingPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusingPatients 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. | Drug | KN3601 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing in people with Refractory Idiopathic Membranous Nephropathy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang He (+86-13588870088, strong_he@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: up to 24 months after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.