Membranous NephropathyEarly Phase 1NCT07535138
Efficacy and Safety of CD19 CAR-γδ T Cells in the Treatment of Relapsed/Refractory Autoimmune Nephropathy
A Early Phase 1 study testing CD19 CAR-γδ T cell in people with Membranous Nephropathy and Lupus Nephritis (LN), run by Air Force Military Medical University, China at 1 site in China.
Trial summary
This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Membranous Nephropathy, Lupus Nephritis (LN), IgA Nephropathy (IgAN)
- What is being tested?
- CD19 CAR-γδ T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Dec 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common Inclusion Criteria:
- Age ≥18 years and ≤65 years;
- Agree to participate in this study and sign the informed consent form;
- Major organ function must meet the following criteria (exceptions are allowed for abnormalities associated with active autoimmune diseases):
- Liver function: ALT, AST or ALP level ≤3 × ULN (upper limit of normal), bilirubin ≤2 × ULN;
- Renal function: eGFR ≥30 mL/min/1.73m²;
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- Pulmonary function: blood oxygen saturation (without oxygen inhalation) ≥92%;
- Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥55%;
- Peripheral blood function: neutrophil count ≥1×10^9/L, hemoglobin ≥60 g/L, platelets ≥30×10^9/L;
- Subjects of childbearing potential (including males and females) must agree to use medically acceptable effective contraceptive measures during the study period and for at least 1 year after CAR-T cell infusion.
- Primary Membranous Nephropathy:
- Diagnosed with primary membranous nephropathy (PMN) by renal biopsy within 18 months before screening;
- Meet the current clinical criteria for refractory PMN: after 6 months of systemic treatment with immunosuppressive regimens recommended by the KDIGO guidelines (including steroids, cyclophosphamide, calcineurin inhibitors, anti-CD20 monoclonal antibodies, etc.), persistent 24-hour urinary protein ≥3.5g and not reduced to less than 50% of the baseline level;
- Relapsed PMN: after achieving complete or partial remission with the above immunosuppressive regimens, 24-hour urinary protein re-elevated to ≥ 3.5g.
- Lupus Nephritis:
- Diagnosed with systemic lupus erythematosus (SLE) before screening, in accordance with the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus;
- Diagnosed with lupus nephritis (LN) by renal biopsy within 18 months before screening, with pathological classification consistent with ISN/RPS lupus nephritis class III/IV (with or without class V);
- SLEDAI-2000 score ≥6 at screening with at least 1 A grade or at least 2 B grades in the BILAG 2004 index; or SLEDAI-2000 score ≥8 at screening;
- Meet the current clinical criteria for refractory LN: after standardized full-dose and full-course high-dose glucocorticoid plus hydroxychloroquine therapy combined with at least 2 immunosuppressive agents of different mechanisms (cyclophosphamide, mycophenolate mofetil, calcineurin inhibitors, etc.), or 1 immunosuppressive agent plus 1 biologic agent (belimumab, anti-CD20 monoclonal antibody, telitacicept, etc.), meet either of the following: ① After 3 months of standardized treatment, 24-hour urinary protein ≥1.5g and not reduced to less than 50% of baseline; ② After 6 months of standardized treatment, prednisone (or equivalent) cannot be tapered to 5 mg/day;
- Relapsed LN: after achieving complete or partial remission with induction remission therapy, disease activity re-increased during maintenance therapy, requiring re-adjustment of the treatment regimen (including increasing glucocorticoid dose or re-initiating induction remission therapy).
- IgA Nephropathy:
- Diagnosed with IgA nephropathy by renal biopsy within 18 months before screening;
- Meet the current clinical criteria for refractory IgA nephropathy: on the basis of standardized ACEI/ARB treatment, after 6 months of systemic immunosuppressive therapy recommended by the KDIGO guidelines (steroids, immunosuppressants, biologics), 24-hour urinary protein ≥0.5g and not reduced to less than 50% of baseline, or eGFR decreased by more than 50% within 3 months;
- Two consecutive 24-hour urinary protein measurements > 0.5g with an interval of ≥ 2 weeks after achieving clinical remission with the above immunosuppressive therapy.
Who cannot join
- Subjects with life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure) assessed by the investigator as unsuitable for enrollment in this study;
- History of alcohol or drug abuse within 24 weeks prior to screening;
- History of malignant tumors other than B-cell lymphoma, except for the following: malignancies confirmed to be cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, and carcinoma in situ at any site;
- Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;
- Complicated with overlapping mixed connective tissue disease, or other diseases that affect the assessment of disease activity;
- Active hepatitis B or hepatitis C virus infection, defined as: subjects positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with peripheral blood high-sensitivity HBV DNA quantification above the lower limit of detection; subjects with peripheral blood high-sensitivity HBV DNA quantification below the lower limit of detection may be enrolled only if the investigator provides appropriate prophylactic antiviral therapy; individuals positive for hepatitis C virus (HCV) antibody with positive peripheral blood high-sensitivity HCV RNA quantification;
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- Coinfection with human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV), Treponema pallidum, cytomegalovirus (CMV), or complicated with selective IgA deficiency;
- Uncontrolled active infection (e.g., active pulmonary tuberculosis, etc., excluding simple urinary tract infection and bacterial pharyngitis); prophylactic administration of antibiotics, antiviral or antifungal agents is permitted;
- Clinical signs of herpes or varicella-zoster virus infection (especially varicella, herpes zoster) within 12 weeks prior to screening;
- History of major cardiovascular diseases within 6 months prior to screening, including NYHA class III or IV heart failure, myocardial infarction, angioplasty or stenting, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac diseases;
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
- Central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);
- Pregnant or lactating women;
- Hypersensitivity to any component of the CAR-γδ T cell product (including fludarabine, cyclophosphamide, tocilizumab);
- Administration of live vaccines within 6 weeks prior to the start of conditioning therapy;
- Participation in other clinical trials within 3 months prior to screening;
- Any other conditions deemed by the investigator to render the subject ineligible for enrollment in this clinical trial.
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
Xijing Hospital
Xi'an, Shaanxi, 710032
Shiren Sun, PhD, +86 17695670709, sunsrsun@163.com
Mingwei Jiang, +86 17695670709, 794480087@qq.com
About this study
Official title: A Clinical Study on the Safety and Efficacy of CD19-Targeted Universal CAR-γδ T Cells in Relapsed/Refractory Autoimmune Nephropathy
This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed/refractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard "3+3" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The planned follow-up duration of this study is 1 years.
- Being tested
- CD19 CAR-γδ T cell
- Medical subject headings
- Glomerulonephritis, Membranous, Lupus Nephritis, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-γδ T cellBiological
Prior to CAR-γδ T cell infusion, patients will receive lymphodepleting chemotherapy consisting of cyclophosphamide combined with fludarabine, followed by infusion of CD19 CAR-γδ T cells at the assigned dose level per their dose-escalation cohort, with target total cell doses of 3×10^7, 1×10^8, and 3×10^8 cells, respectively.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Cell Therapy Group | Experimental | This is a single-arm, open-label study in which all patients receive infusions of different doses of CD19 CAR-γδ T cells in accordance with the "3+3" dose-escalation principle. Receives: Biological: CD19 CAR-γδ T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
The number, frequency, and severity of DLTs experienced by subjects after the first infusion of CD19 CAR-γδ T cells. DLTs are defined by NCI-CTCAE 5.0 and ASTCT consensus for CRS and neurotoxicity.
Measured: Day 0 to Day 28 post-infusion
Incidence of Adverse Events (AEs)
Evaluation of the number, frequency, and severity of all adverse events, including Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs).
Measured: Up to Month 12 post-infusion
Secondary outcomes (12)
Preliminary Clinical Efficacy for Lupus Nephritis
Proportion of subjects achieving complete renal response, major renal response, and partial renal response.
Measured: Month 3, Month 6, Month 9, Month 12,
Preliminary Clinical Efficacy for IgA Nephropathy
Proportion of subjects with 24-hour urine protein quantification below the threshold of 0.3g/24h.
Measured: Month 3, Month 6, Month 9, Month 12,
Preliminary Clinical Efficacy for Membranous Nephropathy
Proportion of subjects achieving complete remission (CR) or partial remission (PR).
Measured: Month 3, Month 6, Month 9, Month 12
The degree of B cell depletion
The degree of B cell depletion at various time points
Measured: Up to 12 Months After CAR-γδT Cell Infusion
Urine Protein
Change from baseline in 24-hour urine protein quantification following a single infusion of CD19 CAR-γδ T Cell
Measured: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Antoantibody
Changes and seronegative rates of serum autoantibodies (e.g., anti-dsDNA antibody, anti-Sm antibody, anti-PLA2R antibody, etc.) from baseline following infusion
Measured: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Serum Albumin
Changes in serum albumin levels from baseline following infusion
Measured: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
eGFR
Change from baseline in estimated glomerular filtration rate(eGFR) quantification following a single infusion of CD19 CAR-T cells
Measured: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Cmax of CAR-T cells
The peak plasma concentration (Cmax) of amplified CAR-γδ T cells in peripheral blood after infusion.
Measured: Within 28 Days After CAR-γδ T Cell Infusion
Tmax of CAR-T cells
The time of amplified CAR-γδ T cells in peripheral blood to reach the maximum concentration (Tmax).
Measured: Within 28 Days After CAR-γδ T Cell Infusion
AUC 0-28d of CAR-T cells
The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d).
Measured: Within 28 Days After CAR-γδ T Cell Infusion
The concentration levels of IL-6
CAR-γδ T-related serum cytokines include IL-6.
Measured: Up to 6 Months After UCAR T-cell Infusion, and at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535138
- Sponsor's protocol ID
- KY20262098-C-1
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of CD19-Targeted Universal CAR-γδ T Cells in Relapsed/Refractory Autoimmune Nephropathy
- ClinicalTrials.gov ID
- NCT07535138
- Acronym / sponsor ID
- KY20262098-C-1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Apr 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.
This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed/refractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard "3+3" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). 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 |
|---|---|---|
| CAR-T Cell Therapy Group | Experimental | Biological: CD19 CAR-γδ T cellThis is a single-arm, open-label study in which all patients receive infusions of different doses of CD19 CAR-γδ T cells in accordance with the "3+3" dose-escalation principle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Common Inclusion Criteria:
- Primary Membranous Nephropathy:
- Lupus Nephritis:
- IgA Nephropathy:
Key exclusion criteria (17 listed)
- Subjects with life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure) assessed by the investigator as unsuitable for enrollment in this study;
- History of alcohol or drug abuse within 24 weeks prior to screening;
- History of malignant tumors other than B-cell lymphoma, except for the following: malignancies confirmed to be cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, and carcinoma in situ at any site;
- Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;
- Complicated with overlapping mixed connective tissue disease, or other diseases that affect the assessment of disease activity;
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 CAR-γδ T cellPrior to CAR-γδ T cell infusion, patients will receive lymphodepleting chemotherapy consisting of cyclophosphamide combined with fludarabine, followed by infusion of CD19 CAR-γδ T cells at the assigned dose level per their dose-escalation cohort, with target total cell doses of 3×10^7, 1×10^8, and 3×10^8 cells, respectively. | Biological | CAR-T Cell Therapy Group |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 0 to Day 28 post-infusion
The number, frequency, and severity of DLTs experienced by subjects after the first infusion of CD19 CAR-γδ T cells. DLTs are defined by NCI-CTCAE 5.0 and ASTCT consensus for CRS and neurotoxicity.
Incidence of Adverse Events (AEs)
Time frame: Up to Month 12 post-infusion
Evaluation of the number, frequency, and severity of all adverse events, including Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs).
12 secondary outcomes
Preliminary Clinical Efficacy for Lupus Nephritis
Time frame: Month 3, Month 6, Month 9, Month 12,
Preliminary Clinical Efficacy for IgA Nephropathy
Time frame: Month 3, Month 6, Month 9, Month 12,
Preliminary Clinical Efficacy for Membranous Nephropathy
Time frame: Month 3, Month 6, Month 9, Month 12
The degree of B cell depletion
Time frame: Up to 12 Months After CAR-γδT Cell Infusion
Urine Protein
Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Antoantibody
Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Serum Albumin
Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
eGFR
Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Cmax of CAR-T cells
Time frame: Within 28 Days After CAR-γδ T Cell Infusion
Tmax of CAR-T cells
Time frame: Within 28 Days After CAR-γδ T Cell Infusion
AUC 0-28d of CAR-T cells
Time frame: Within 28 Days After CAR-γδ T Cell Infusion
The concentration levels of IL-6
Time frame: Up to 6 Months After UCAR T-cell Infusion, and at Month 12
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 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 CAR-γδ T cell in people with Membranous Nephropathy and Lupus Nephritis (LN), run by Air Force Military Medical University, China 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 24 inclusion and 17 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 16 Apr 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 Shiren Sun, PhD (+86 17695670709, sunsrsun@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 Toxicities (DLTs) (time frame: Day 0 to Day 28 post-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 16 Apr 2026.