Refractory Membranous NephropathyPhase 1NCT07266181
Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy
A Phase 1 study testing All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment. in people with Refractory Membranous Nephropathy, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.
Trial summary
This study is a single-center, prospective, exploratory Phase I clinical trial initiated by the team led by Associate Professor He Lijie from the Department of Nephrology, Xijing Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Membranous Nephropathy
- What is being tested?
- All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 31 Jul 2028
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed as primary membranous nephropathy (PMN) by renal biopsy.
- Classified as moderate-risk or high-risk refractory membranous nephropathy (rMN).
- Moderate-risk rMN is defined as: eGFR ≥ 90 ml/min/1.73m² AND 24-hour urinary protein > 3.5g/d, with a reduction of no more than 50% within 6 months of receiving renin-angiotensin system inhibitor (RASi) therapy.
- High-risk rMN is defined as meeting one of the following:
- eGFR < 60 ml/min/1.73m² and/or persistent proteinuria > 8g/d for more than 6 months.
- Normal eGFR with proteinuria > 3.5g/d and ≤50% reduction after 6 months of RASi therapy, PLUS at least one of the following: Serum albumin < 25g/L; PLA2R antibody > 50 RU/mL; Urinary α1-microglobulin > 40 μg/min; Urinary IgG > 1 μg/min; Urinary β2-microglobulin > 250 mg/d; IgG/albumin clearance ratio > 0.20.
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- Diagnosis of rMN requires failure of adequate first-line immunosuppressive therapy (≥6 months of steroids+cyclophosphamide, CNI, or rituximab), defined by any of the following: persistent high-titer anti-PLA2R antibody; for antibody-negative patients, persistent nephrotic syndrome (protein >3.5g/d, albumin <30g/L); <50% reduction in proteinuria.
- Age ≥ 18 years.
- Adequate organ function, defined as:
- Renal: eGFR ≥ 30 ml/min/1.73m².
- Hepatic: ALT and AST ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN.
- Cardiac: LVEF ≥ 50%; NYHA Class I or II; No significant arrhythmias requiring intervention; No major cardiovascular events within the past 6 months.
- Respiratory: SpO2 > 92% on room air.
- Ability to understand and willingness to sign an Informed Consent Form.
Who cannot join
- Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).
- Active infection requiring IV antibiotics, active tuberculosis, or positive viral serology indicating active infection, including:
- HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
- HCV: HCV Ab (+) with detectable HCV RNA.
- HIV Ab (+).
- Active EBV or CMV infection (IgM+ or DNA above normal).
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- Positive syphilis (Treponema pallidum) antibody (requires evaluation for active infection).
- Severe uncontrolled comorbidities, including:
- Uncontrolled hypertension (persistent SBP > 160 mmHg or DBP > 100 mmHg).
- Uncontrolled diabetes (HbA1c > 8% or random glucose ≥11.1 mmol/L) or diabetic nephropathy.
- Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months.
- Active peptic ulcer or gastrointestinal bleeding within the past 6 months.
- Severe congenital or acquired immunodeficiency.
- Severe CNS diseases (e.g., catastrophic APS, uncontrolled epilepsy).
- End-stage organ failure not attributable to PMN.
- History of malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid cancer.
- Specific treatment history or plans, including:
- Prior receipt of any cell therapy (e.g., MSCs, HSCT).
- Major surgery within 24 weeks before or planned within 24 weeks after enrollment.
- Planned kidney transplantation within 3 years.
- History of substance abuse.
- Participation in another interventional clinical trial within 3 months prior to enrollment.
- Pregnant or lactating women.
- Inability to understand the study or provide informed consent (e.g., severe dementia, mental illness).
- Any other condition deemed by the investigator to increase risk, interfere with assessment, or affect compliance.
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
Department of Nephrology, Xijing Hospital
Xi'an, China, 710012
Jipeng Li, 8684775197, shaona@ldy.edu.rs
About this study
Official title: Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in the Treatment of Refractory Membranous Nephropathy
This study is a single-center, prospective, exploratory Phase I clinical trial initiated by the team led by Associate Professor He Lijie from the Department of Nephrology, Xijing Hospital.
Prior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells/kg.
In the subsequent 2 weeks, patients will be hospitalized for monitoring of vital signs and adverse reactions. The planned follow-up duration of this study is 1 years.
- Conditions
- Refractory Membranous Nephropathy
- Being tested
- All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.Other
Prior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| To preliminarily evaluate the safety and efficacy of CD19 CAR-T in refractory membranous nephropathy | Other | Not described Receives: Other: All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT in rMN subjects after a single infusion of CD19 CAR-T cells
Definition: The DLT evaluated in this study is assessed within two time windows: 28 days (Day 0 to Day 28) and 3 months (Day 28 to Month 3) after CAR-T cell infusion. These time windows are selected based on the typical timeline of CAR-T cell expansion, activity, and potential occurrence of major toxicities in vivo.
The determination of DLT must meet all the following criteria:1.DLT must be an adverse event judged by the investigator as probably or definitely related to CAR-T cell infusion, and cannot be attributed to underlying diseases, comorbidities, or toxicities from concomitant medications;2.The adverse event must reach a severity grade of ≥ Grade 3 (per CTCAE v5.0) or ≥ Grade 3 specific toxicity grading criteria (e.g., IEC-HS grading).
Measured: 28 days and 3 months after infusion
Incidence of AE in rMN subjects after a single infusion of CD19 CAR-T cells
Severity grading is based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0:
Grade 1: Mild; asymptomatic or mild symptoms; only clinically or diagnostically detectable; no treatment required.
Grade 2: Moderate; requires minor, local, or non-invasive treatment; limitation in age-appropriate instrumental activities of daily living.
Grade 3: Severe or medically significant but not immediately life-threatening; results in hospitalization or prolongation of existing hospitalization; disabling; limitation in self-care activities of daily living.
Grade 4: Life-threatening; requires urgent treatment. Grade 5: Death related to complications.
Measured: 12 months after infusion
Secondary outcomes (18)
Overall response rate (CR+PR) in rMN subjects after cell infusion
- Definition of rMN CR: Disappearance of the patient's clinical symptoms and signs; urine protein reduced to <0.3 g/day or UACR <300 mg/g; with normal levels of serum albumin (ALB) and serum creatinine (Scr).
- Definition of rMN PR: Improvement in clinical symptoms and signs; urine protein decreased by more than 50% compared with baseline, and reduced to 0.3-3.5 g/day or UACR 300-3500 mg/g.
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Proportion of rMN subjects achieving CR after cell infusion
Definition of rMN CR: Disappearance of the patient's clinical symptoms and signs; urine protein reduced to <0.3 g/day or UACR <300 mg/g; with normal levels of serum albumin (ALB) and serum creatinine (Scr).
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Proportion of rMN subjects achieving PR after cell infusion
Definition of rMN PR: Improvement in clinical symptoms and signs; urine protein decreased by more than 50% compared with baseline, and reduced to 0.3-3.5 g/day or UACR 300-3500 mg/g.
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
rMN recurrence after cell infusion
Definition of rMN recurrence: After NR or PR, the patient's urine protein rises again to >3.5 g/day or UACR >3500 mg/g; frequent recurrence is defined as more than 2 recurrences within 6 months or more than 4 recurrences within 12 months.
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
eGFR
Change in eGFR from baseline in rMN subjects after a single infusion of CD19 CAR-T cells. Estimated glomerular filtration rate, calculated using the CKD-EPI 2021 formula
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Urine protein
Change in urine protein from baseline in rMN subjects after a single infusion of CD19 CAR-T cells, 24-hour urine protein quantification
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
UACR
Change in UACR from baseline in rMN subjects after a single infusion of CD19 CAR-T cells, Random urine
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
anti-PLA2R antibody
Change in serum anti-PLA2R antibody from baseline in rMN subjects after a single infusion of CD19 CAR-T cells. Venous blood
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Scr, CysC
Change in serum renal function from baseline in rMN subjects after a single infusion of CD19 CAR-T cells.Venous blood
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Routine blood test
Change in blood cells in rMN subjects after a single infusion of CD19 CAR-T cells.Venous blood
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
CRP
Change in CRP in rMN subjects after a single infusion of CD19 CAR-T cells.Venous blood
Measured: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Serum complements C3, C4
Change in complements in rMN subjects after a single infusion of CD19 CAR-T cells.
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
IgE、IgA、IgG、IgM
Change in immunoglobulins in rMN subjects after a single infusion of CD19 CAR-T cells.
Measured: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
CAR copy number
Change in CAR copy parameters in rMN subjects after a single infusion of CD19 CAR-T cells
Measured: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month), Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Ferritin level
Change in ferritin in rMN subjects after a single infusion of CD19 CAR-T cells
Measured: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Cytokine panel
Change in cytokines in rMN subjects after a single infusion of CD19 CAR-T cells
Measured: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Peripheral blood lymphocyte subset count
Change in peripheral blood lymphocyte subsets in rMN subjects after a single infusion of CD19 CAR-T cells
Measured: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
The surface of peripheral blood B cell subsets
Expression level of CD19 on the surface of peripheral blood B cell subsets in rMN subjects after a single infusion of CD19 CAR-T cells
Measured: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start8 Dec 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Jipeng, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266181
- Sponsor's protocol ID
- KY20252388-F-1
- Status last verified
- Aug 2025
- First submitted
- 24 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in the Treatment of Refractory Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT07266181
- Acronym / sponsor ID
- KY20252388-F-1
- Conditions
- Refractory Membranous Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Dec 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.
This study is a single-center, prospective, exploratory Phase I clinical trial initiated by the team led by Associate Professor He Lijie from the Department of Nephrology, Xijing Hospital.
Prior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells/kg.
In the subsequent 2 weeks, patients will be hospitalized for monitoring of vital signs and adverse reactions. The planned follow-up duration of this study is 1 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To preliminarily evaluate the safety and efficacy of CD19 CAR-T in refractory membranous nephropathy | Other | Other: All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmed as primary membranous nephropathy (PMN) by renal biopsy.
- Classified as moderate-risk or high-risk refractory membranous nephropathy (rMN).
- Moderate-risk rMN is defined as: eGFR ≥ 90 ml/min/1.73m² AND 24-hour urinary protein > 3.5g/d, with a reduction of no more than 50% within 6 months of receiving renin-angiotensin system inhibitor (RASi) therapy.
- High-risk rMN is defined as meeting one of the following:
- Diagnosis of rMN requires failure of adequate first-line immunosuppressive therapy (≥6 months of steroids+cyclophosphamide, CNI, or rituximab), defined by any of the following: persistent high-titer anti-PLA2R antibody; for antibody-negative patients, persistent nephrotic syndrome (protein >3.5g/d, albumin <30g/L); <50% reduction in proteinuria.
Key exclusion criteria (25 listed)
- Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).
- Active infection requiring IV antibiotics, active tuberculosis, or positive viral serology indicating active infection, including:
- Severe uncontrolled comorbidities, including:
- History of malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid cancer.
- Specific treatment history or plans, including:
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 |
|---|---|---|
| All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.Prior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells/kg. | Other | To preliminarily evaluate the safety and efficacy of CD19 CAR-T in refractory membranous nephropathy |
Primary outcome
Incidence of DLT in rMN subjects after a single infusion of CD19 CAR-T cells
Time frame: 28 days and 3 months after infusion
Definition: The DLT evaluated in this study is assessed within two time windows: 28 days (Day 0 to Day 28) and 3 months (Day 28 to Month 3) after CAR-T cell infusion. These time windows are selected based on the typical timeline of CAR-T cell expansion, activity, and potential occurrence of major toxicities in vivo. The determination of DLT must meet all the following criteria:1.DLT must be an adverse event judged by the investigator as probably or definitely related to CAR-T cell infusion, and cannot be attributed to underlying diseases, comorbidities, or toxicities from concomitant medications;2.The adverse event must reach a severity grade of ≥ Grade 3 (per CTCAE v5.0) or ≥ Grade 3 specific toxicity grading criteria (e.g., IEC-HS grading).
Incidence of AE in rMN subjects after a single infusion of CD19 CAR-T cells
Time frame: 12 months after infusion
Severity grading is based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0: Grade 1: Mild; asymptomatic or mild symptoms; only clinically or diagnostically detectable; no treatment required. Grade 2: Moderate; requires minor, local, or non-invasive treatment; limitation in age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; results in hospitalization or prolongation of existing hospitalization; disabling; limitation in self-care activities of daily living. Grade 4: Life-threatening; requires urgent treatment. Grade 5: Death related to complications.
18 secondary outcomes
Overall response rate (CR+PR) in rMN subjects after cell infusion
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Proportion of rMN subjects achieving CR after cell infusion
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Proportion of rMN subjects achieving PR after cell infusion
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
rMN recurrence after cell infusion
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
eGFR
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Urine protein
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
UACR
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
anti-PLA2R antibody
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Scr, CysC
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Routine blood test
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
CRP
Time frame: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Serum complements C3, C4
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
IgE、IgA、IgG、IgM
Time frame: Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
CAR copy number
Time frame: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month), Month 2, Month 3, Month 6, Month 9, Month 12, Month 18 (if applicable), Month 24 (if applicable) after infusion
Ferritin level
Time frame: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Cytokine panel
Time frame: Day 2, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
Peripheral blood lymphocyte subset count
Time frame: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) after infusion
The surface of peripheral blood B cell subsets
Time frame: Day 2, Day 5, Day 7, Day 10 or 14, Day 21, Day 28 (1 month) 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 24 Dec 2025.
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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 Phase 1 study testing All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment. in people with Refractory Membranous Nephropathy, run by The First Affiliated Hospital of Air Force 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 25 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 24 Dec 2025. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jipeng Li (8684775197, shaona@ldy.edu.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT in rMN subjects after a single infusion of CD19 CAR-T cells (time frame: 28 days and 3 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 24 Dec 2025.