Relapsed/Refractory Immune NephropathyEarly Phase 1NCT07241468
An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
A Early Phase 1 study testing anti-CD19/BCMA U CAR T in people with Relapsed/Refractory Immune Nephropathy and Relapsed/Refractory Immune-mediated Kidney Disease, run by Changhai Hospital 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 U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed/Refractory Immune Nephropathy, Relapsed/Refractory Immune-mediated Kidney Disease
- What is being tested?
- anti-CD19/BCMA U CAR T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 30 Dec 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- 2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;
- The functions of critical organs meet the following requirements:
- Neutrophil count ≥ 1 x 10^9/L, Hemoglobin ≥60g/L, platelets ≥ 50×109/L,
- Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,
- Coagulation function: International standardized ratio (INR) ≤ 1.5x ULN, prothrombin time (PT) ≤1.5 x ULN,
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- Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.
- Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;
- Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
- Specific inclusion criteria:
- High-risk or relapsed/refractory primary membranous nephropathy
- Primary membranous nephropathy diagnosed pathologically by renal biopsy;
- Meets the clinical criteria for high-risk or recurrent/refractory membranous nephropathy, defined as:
- Subjects at risk who meet any of the following criteria: a) estimated glomerular filtration rate (eGFR, CKD-EPI equation) <60 mL/min/1.73m², and/or urine protein >8g/day persisting for more than 6 months;b) normal GFR, urinary protein >3.5 g/d, treated with ACEI/ARB for 6 months, urinary protein reduction <50%, and serum albumin <25 g/l or aPLA2R >50 RU/mL;
- Refractory membranous nephropathy subjects are defined as those who have shown poor response or resistance to previous immunosuppressive treatments (including corticosteroids and/or cytotoxic drugs, immunosuppressants and/or biologics), defined as persistent proteinuria ≥3.5g/day with a reduction of <50% compared to baseline;
- Recurrent membranous nephropathy is defined as a relapse (24-hour urinary protein ≥3.5 g) in subjects who have achieved complete or partial remission following treatment;
- Subjects with relapsed/refractory MN and eGFR ≥ 45 mL/min/1.73 m2 during the screening period;
- Primary IgA nephropathy pathologically confirmed by renal biopsy;
- Subjects have medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening;
- Subjects have been treated with hormones and/or cytotoxic drugs, immunosuppressants and/or biological agents (including but not limited to anti-CD20 monoclonal antibodies) for more than 6 months, and the 24-hour urine protein is ≥1.0 g; subjects with a rapidly progressive decline in kidney function (eGFR decreases by ≥50% within 3 months); or The subject relapsed after achieving complete remission/partial remission (CR/PR) following treatment (24-hour urine protein ≥1.0 g);
- Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening;
- Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis;
- ANCA-related antibodies positive (MPO-ANCA or PR3-ANCA positive);
- Kidney biopsy pathology is consistent with ANCA-associated vasculitis renal damage;
- Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis;
- At least two abnormalities related to the kidneys in the BVAS score;
- Subjects meeting the definition of relapsed/refractory: standard treatment is ineffective or disease activity recurs after remission. Definition of conventional treatment: using glucocorticoids (more than 1mg/kg/day) and cyclophosphamide, along with any one of the following immunomodulatory drugs for ≥3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and thalidomide;
- Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening
Who cannot join
- Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study
- Common exclusion Criteria:
- Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;
- The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;
- Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
- Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;
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- Subjects with congenital immunoglobulin deficiency;
- The subject has other malignant tumours (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder cancer, and breast cancer with disease-free survival of over 5 years);
- Subjects with end-stage renal failure;
- Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have peripheral blood HBV DNA titres above the detection limit; subjects who are positive for hepatitis C virus (HCV) antibodies and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibodies; subjects who test positive for syphilis;
- Subjects have mental illness and severe cognitive impairment;
- Subjects who have participated in other clinical trials within 6 months prior to enrolment;
- Female participants who are pregnant or planning to conceive;
- Subjects with hypertension and diabetes uncontrolled by medication;
- Researchers believe that there are other reasons why some subjects cannot be included in this study;
- Specific exclusion Criteria:
- Relapsed/Refractory Primary Membranous Nephropathy
- Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;
- Relapsed/Refractory IgA Nephropathy
- Exclude secondary IgA nephropathy, including but not limited to: anaphylactic purpura, ankylosing spondylitis, systemic lupus erythematosus, desiccation syndrome, viral hepatitis, cirrhosis of the liver, rheumatoid arthritis, and mixed connective tissue disease; or in combination with other renal diseases confirmed by renal biopsy;
- Crescentic nephritis (pathologic diagnosis of >50% crescentic bodies), micrognathic nephropathy with IgA deposition, and other specific types of pathologic or clinical renal disease;
- Relapsed/refractory ANCA-associated vasculitis kidney damage
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2;
- If subjects have alveolar haemorrhage and requires invasive lung ventilation, the expected duration exceeds the screening time.
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, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai
Zhiyong Guo, Dr, 86-021-31161406, chguozhiyong@126.com
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease
- Conditions
- Relapsed/Refractory Immune Nephropathy, Relapsed/Refractory Immune-mediated Kidney Disease
- Being tested
- anti-CD19/BCMA U CAR T
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/BCMA U CAR TBiological
To evaluate the safety and effectiveness of anti-CD19/BCMA CAR T cells (KN3601) in patients with immune nephropathy. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA U CAR T cells infusion.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19/BCMA U CAR T cells | Experimental | Not described Receives: Biological: anti-CD19/BCMA U CAR T |
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 Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
Secondary outcomes (4)
The overall response rate (ORR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
Disease control rate (DCR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
B cell depletion rate
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
B cell reconstitution
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
Measured: up to 52 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Immune NephropathyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241468
- Sponsor's protocol ID
- CHEC2025-362
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
- ClinicalTrials.gov ID
- NCT07241468
- Acronym / sponsor ID
- CHEC2025-362
- Conditions
- Relapsed/Refractory Immune Nephropathy, Relapsed/Refractory Immune-mediated Kidney Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Nov 2025 (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 U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19/BCMA U CAR T cells | Experimental | Biological: anti-CD19/BCMA U CAR T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- 2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;
- The functions of critical organs meet the following requirements:
- Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;
- Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Key exclusion criteria (24 listed)
- Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study
- Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;
- The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;
- Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
- Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;
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 |
|---|---|---|
| anti-CD19/BCMA U CAR TTo evaluate the safety and effectiveness of anti-CD19/BCMA CAR T cells (KN3601) in patients with immune nephropathy. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA U CAR T cells infusion. | Biological | anti-CD19/BCMA U CAR T cells |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: up to 52 weeks after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 52 weeks after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy
4 secondary outcomes
The overall response rate (ORR)
Time frame: up to 52 weeks after infusion
Disease control rate (DCR)
Time frame: up to 52 weeks after infusion
B cell depletion rate
Time frame: up to 52 weeks after infusion
B cell reconstitution
Time frame: up to 52 weeks after infusion
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 6 Feb 2026.
- Individual participant dataSharing planned: No
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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 anti-CD19/BCMA U CAR T in people with Relapsed/Refractory Immune Nephropathy and Relapsed/Refractory Immune-mediated Kidney Disease, run by Changhai Hospital 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 28 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 6 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 Zhiyong Guo, Dr (86-021-31161406, chguozhiyong@126.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 52 weeks 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 6 Feb 2026.