ClinicalTrials.gg
Not yet recruitingNCT07535138Updated Apr 16, 2026

Efficacy and Safety of CD19 CAR-γδ T Cells in the Treatment of Relapsed/Refractory Autoimmune Nephropathy

An Early Phase 1 interventional study of CD19 CAR-γδ T cell in Membranous Nephropathy, Lupus Nephritis (LN) and IgA Nephropathy (IgAN), sponsored by Air Force Military Medical University, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Air Force Military Medical University, China · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies in Glomerulonephritis, Membranous with a site in China — 29 open to participants now, 37 under way, 10 of them phase 3. Glomerulonephritis, Membranous · China.

Planned enrollment
44th of 50
15 · median 77
Started
2026
with 5 others
Phase 1
7 of 60
6 open now
Primary completion
2028-06
later than 30 of 36 live
Registered
57th of 60
by date

Among the 60 studies in Glomerulonephritis, Membranous with a site in China, this one is the 44th largest by planned enrollment of the 50 interventional ones that give a count, is one of 6 that started in 2026, is one of 7 in phase 1, reaches primary completion later than 30 of the 36 other live ones, and was the 57th registered.

Glomerulonephritis, Membranous

144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.

Browse Glomerulonephritis, Membranous studies →

Open to participants now

29 of the 60 studies in Glomerulonephritis, Membranous with a site in China are open now. Recruiting first, the newest first:

24 more — sign in →

All 29 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 40 Glomerulonephritis, Membranous studies recruiting now, 14 (35%) set no upper age limit and 13 (33%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 60 studies in Glomerulonephritis, Membranous with a site in China, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Membranous Nephropathy
  • Lupus Nephritis (LN)
  • IgA Nephropathy (IgAN)
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Common Inclusion Criteria:

    1. Age ≥18 years and ≤65 years;
    2. Agree to participate in this study and sign the form;
    3. Major organ function must meet the following criteria (exceptions are allowed for abnormalities associated with active diseases):

      1. Liver function: , AST or ALP level ≤3 × (upper limit of normal), ≤2 × ULN;
      2. Renal function: ≥30 mL/min/1.73m²;
      3. Pulmonary function: blood oxygen saturation (without oxygen inhalation) ≥92%;
      4. Cardiac function: hemodynamically stable, (LVEF) ≥55%;
      5. Peripheral blood function: ≥1×10\^9/L, ≥60 g/L, ≥30×10\^9/L;
    4. Subjects of (including males and females) must agree to use medically acceptable effective measures during the study period and for at least 1 year after CAR-T cell infusion.
  • Primary Membranous Nephropathy:

    1. Diagnosed with primary membranous nephropathy (PMN) by renal within 18 months before screening;
    2. Meet the current clinical criteria for PMN: after 6 months of systemic treatment with regimens recommended by the KDIGO guidelines (including , 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;
    3. Relapsed PMN: after achieving complete or partial remission with the above immunosuppressive regimens, 24-hour urinary protein re-elevated to ≥ 3.5g.
  • Lupus Nephritis:

    1. Diagnosed with systemic lupus erythematosus (SLE) before screening, in accordance with the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus;
    2. 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);
    3. 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;
    4. 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;
    5. 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:

    1. Diagnosed with IgA nephropathy by renal biopsy within 18 months before screening;
    2. 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;
    3. Two consecutive 24-hour urinary protein measurements > 0.5g with an interval of ≥ 2 weeks after achieving clinical remission with the above immunosuppressive therapy.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. History of alcohol or drug abuse within 24 weeks prior to screening;
  3. History of malignant tumors other than B-cell lymphoma, except for the following: 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;
  4. Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;
  5. Complicated with overlapping mixed connective tissue disease, or other diseases that affect the assessment of disease activity;
  6. Active or 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;
  7. Coinfection with (HIV), human T-cell leukemia virus (HTLV), Treponema pallidum, cytomegalovirus (CMV), or complicated with selective IgA deficiency;
  8. 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;
  9. Clinical signs of herpes or varicella-zoster virus infection (especially varicella, herpes zoster) within 12 weeks prior to screening;
  10. History of major cardiovascular diseases within 6 months prior to screening, including class III or IV heart failure, myocardial infarction, angioplasty or stenting, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other cardiac diseases;
  11. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
  12. Central nervous system disorders caused by or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);
  13. Pregnant or lactating women;
  14. to any component of the CAR-γδ T cell product (including fludarabine, cyclophosphamide, tocilizumab);
  15. Administration of within 6 weeks prior to the start of conditioning therapy;
  16. Participation in other clinical trials within 3 months prior to screening;
  17. Any other conditions deemed by the investigator to render the subject ineligible for enrollment in this clinical trial.
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    CAR-T Cell Therapy Group

    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.

    Biological: CD19 CAR-γδ T cell

Interventions

  • BiologicalCD19 CAR-γδ T cell

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0 to Day 28 post-infusion

  2. 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).

    Time frame: Up to Month 12 post-infusion

Secondary outcomes

  1. Preliminary Clinical Efficacy for Lupus Nephritis

    Proportion of subjects achieving complete renal response, major renal response, and partial renal response.

    Time frame: Month 3, Month 6, Month 9, Month 12,

  2. Preliminary Clinical Efficacy for IgA Nephropathy

    Proportion of subjects with 24-hour urine protein quantification below the threshold of 0.3g/24h.

    Time frame: Month 3, Month 6, Month 9, Month 12,

  3. Preliminary Clinical Efficacy for Membranous Nephropathy

    Proportion of subjects achieving complete remission (CR) or partial remission (PR).

    Time frame: Month 3, Month 6, Month 9, Month 12

  4. The degree of B cell depletion

    The degree of B cell depletion at various time points

    Time frame: Up to 12 Months After CAR-γδT Cell Infusion

  5. Urine Protein

    Change from baseline in 24-hour urine protein quantification following a single infusion of CD19 CAR-γδ T Cell

    Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12

  6. Antoantibody

    Changes and seronegative rates of serum autoantibodies (e.g., anti-dsDNA antibody, anti-Sm antibody, anti-PLA2R antibody, etc.) from baseline following infusion

    Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12

  7. Serum Albumin

    Changes in serum albumin levels from baseline following infusion

    Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12

  8. eGFR

    Change from baseline in estimated glomerular filtration rate(eGFR) quantification following a single infusion of CD19 CAR-T cells

    Time frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12

  9. Cmax of CAR-T cells

    The peak plasma concentration (Cmax) of amplified CAR-γδ T cells in peripheral blood after infusion.

    Time frame: Within 28 Days After CAR-γδ T Cell Infusion

  10. Tmax of CAR-T cells

    The time of amplified CAR-γδ T cells in peripheral blood to reach the maximum concentration (Tmax).

    Time frame: Within 28 Days After CAR-γδ T Cell Infusion

  11. AUC 0-28d of CAR-T cells

    The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d).

    Time frame: Within 28 Days After CAR-γδ T Cell Infusion

  12. The concentration levels of IL-6

    CAR-γδ T-related serum cytokines include IL-6.

    Time frame: Up to 6 Months After UCAR T-cell Infusion, and at Month 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Jun 2028, 25 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2026
First posted
Apr 16, 2026
StartEst.
May 1, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Dec 30, 2028
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07535138
Responsible party
Shiren sun (Director, Department of Nephrology, Air Force Military Medical University, China) — Principal investigator
First posted
Apr 16, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Apr 16, 2026

Study contacts

Shiren Sun, PhD
Contact
sunsrsun@163.com
+86 17695670709
Mingwei Jiang
Contact
794480087@qq.com
+86 17695670709

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion