Study of Surovatamig and Human IgG4 Kappa Monoclonal Antibody Against CD3 and CD19 in Adults with Antibody-Mediated Kidney Disease

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What is this study about?

The study focuses on adults with Antibody-mediated Kidney Disease, a condition where the immune system creates antibodies that damage the kidneys, leading to excess protein in the urine (called proteinuria). The investigational medicine being tested is called surovatamig, a type of monoclonal antibody designed to target specific immune cells (identified as CD3 and CD19). The drug is given as a subcutaneous injection (under the skin) in a liquid form.

The purpose of the study is to evaluate the safety, tolerability, and how the body handles the drug (pharmacokinetics) as well as its effect on reducing protein loss in urine. Researchers will monitor side effects, vital signs, and laboratory tests, and will also measure changes in the urine protein-to-creatinine ratio (UPCR) and kidney function using the estimated glomerular filtration rate (eGFR).

Participants will receive the study medication by injection at regular intervals over several months, with clinic visits for assessments and urine or blood collection to check protein levels, antibody levels such as anti-PLA2R antibody, and the number of immune cells called B-cell. The study continues for up to two years, allowing researchers to see both short‑term and longer‑term effects of the treatment.

1 confirmation of enrollment and first study visit

after agreeing to join the study, a study coordinator confirms enrollment and schedules the first study visit.

during this visit, personal information is verified and the study schedule is explained.

2 baseline safety and health assessments

a series of baseline measurements are taken to document health status before receiving any study medication.

measurements include vital signs (blood pressure, heart rate, temperature), a physical examination, routine laboratory tests, and a 12‑lead electrocardiogram (ECG).

a 24‑hour urine collection is performed to measure proteinuria (the amount of protein in the urine).

blood samples are drawn to assess kidney function, the level of anti‑PLA2R antibodies, and the count of B‑cells in peripheral blood.

3 first administration of surovatamig

the study medication, surovatamig, is given as a subcutaneous injection (injection under the skin).

the exact dose and frequency follow the study protocol and are administered by trained study staff.

4 ongoing medication administration

subsequent doses of surovatamig are provided according to the schedule defined in the study protocol.

each dose is delivered by subcutaneous injection at the clinic or a designated study location.

5 regular safety monitoring visits

the participant attends scheduled clinic visits throughout the study period.

at each visit, vital signs are recorded, a brief physical examination is performed, and routine laboratory tests are collected.

an ECG may be repeated as needed to monitor heart health.

the participant is asked to report any adverse events (side effects) that have occurred since the previous visit.

6 proteinuria assessment at 6 months

at the six‑month mark, a second 24‑hour urine collection is performed to evaluate changes in proteinuria.

the result is compared with the baseline measurement to determine the effect of the medication.

7 comprehensive assessments at 24 months

at the end of the 24‑month study period, a final set of evaluations is conducted.

these include a repeat 24‑hour urine collection for proteinuria, blood tests for anti‑PLA2R antibody titer, B‑cell count, and kidney function (estimated glomerular filtration rate, eGFR).

the participant also completes a patient‑reported outcome questionnaire to capture any changes in health status.

8 study completion and medication discontinuation

after the final assessments, the study medication is discontinued.

the participant receives a summary of study findings and any necessary follow‑up instructions.

Who Can Join the Study?

Be between 18 and 75 years old (or the legal age of consent in your area) when you sign the informed consent.
Have a diagnosis of anti‑PLA2R antibody‑positive primary membranous nephropathy (pMN) as defined by the KDIGO 2021 guidelines. Anti‑PLA2R antibodies are proteins in the blood that target a kidney protein, and primary membranous nephropathy is a type of kidney disease.
Have taken standard kidney‑protecting medicine called an angiotensin‑converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 4 weeks, unless you cannot tolerate them, have a medical reason not to use them, or have low blood pressure.
Have an estimated glomerular filtration rate (eGFR) that meets the study’s minimum level (the exact value will be given by the study) using the 2021 CKD‑EPI creatinine equation. eGFR is a measure of how well your kidneys filter waste.
Test positive for anti‑PLA2R antibodies (the same antibody mentioned above).
Show adequate haematological function, meaning your blood cells and clotting ability are within normal limits.
Have a blood count of CD19+ B cells that meets the study’s required minimum (the specific number will be provided). CD19+ B cells are a type of immune cell.
Have blood levels of immunoglobulin G (IgG) that meet the study’s required minimum (the specific number will be provided). IgG is an antibody that helps your immune system.
Be assigned male or female at birth (any gender identity is accepted) and use contraception as required by local regulations, either by you or your partner, during the study.

Who Cannot Join the Study?

Having any serious disease that the doctor believes could make the study unsafe or could affect the study results.
Having an infection that required a hospital stay or medicines given through a vein (IV antibiotics) and finishing treatment less than 4 weeks before signing the consent form.
Having an infection that required oral antibiotics or other infection medicines taken by mouth within 2 weeks before signing the consent form.
Having repeated infections that needed a hospital stay or IV antibiotics (for example, three or more of the same infection, including serious fungal infections, in the past year).
Current or past active or hidden TB (tuberculosis). This includes any signs or symptoms of active TB, past examinations suggesting TB, a chest X‑ray or CT scan within the last 12 weeks showing TB, close contact with someone who has active TB, or a positive or indeterminate TB blood test (QuantiFERON‑TB Gold).
Having HIV infection, confirmed by a laboratory test.
Having an active infection with EBV (Epstein‑Barr virus) or CMV (cytomegalovirus), as judged by the doctor.
Evidence of chronic or active hepatitis B, shown by a positive HBsAg or HBcAb blood test.
Evidence of chronic or active hepatitis C, shown by a positive viral RNA test or antibody test, unless the infection has been successfully treated and tests have been negative for at least 12 weeks.
Unusual vital signs (such as blood pressure or heart rate) after sitting quietly for 10 minutes.
Abnormal results on an ECG (electrocardiogram) that the doctor thinks make participation unsafe.
Having other conditions that can cause membranous nephropathy, such as autoimmune diseases, infections, cancers, HIV infection, or liver disease.
Taking high‑dose corticosteroids (more than 20 mg of prednisolone or an equivalent) within the past 2 months.
Having received B‑cell‑depleting therapy (medicines that reduce certain immune cells) such as ocrelizumab, ofatumumab, obinutuzumab, or rituximab within the past 9 months.
Taking any immunomodulatory therapy (drugs that change how the immune system works) within the past 3 months.
Having diabetes with a hemoglobin A1C level higher than 8.5 % at screening.
Having any current cancer, except for treated non‑melanoma skin cancer, early cervical cancer (carcinoma in situ), or low‑risk prostate cancer that is being monitored without treatment; also, having had any cancer in the past 3 years (except the same exceptions).
Past history of HLH/MAS (very serious immune system disorders called hemophagocytic lymphohistiocytosis or macrophage activation syndrome).
Significant problems of the brain or spinal cord (CNS), such as Parkinson’s disease, stroke, severe seizures, dementia, severe mental illness, or other major neurological conditions.
Any serious disease diagnosed or treated within the past 6 months that the study considers important.
Any significant opportunistic infection (an infection that occurs because the immune system is weakened) that the doctor deems relevant.
Having a long‑lasting infection such as osteomyelitis (bone infection) or bronchiectasis (serious lung condition) with treatment completed less than 2 months before signing the consent form (chronic nail infections are not excluded).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Jan Yperman Ziekenhuis	Ieper	Belgium
Ospedale San Giovanni Bosco	Turin	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	28.09.2026
France	Not yet recruiting	28.09.2026
Italy	Not yet recruiting	28.09.2026
Poland	Not yet recruiting	28.09.2026
Spain	Not yet recruiting	28.09.2026

Trial locations

Investigated Drugs:

Human Igg4 Kappa Monoclonal Antibody Against Cd3 And Cd19

AZD0486 is an investigational human IgG4 kappa monoclonal antibody that is designed to bind to two proteins on immune cells called CD3 and CD19. By attaching to these proteins, the antibody may modify the activity of certain immune cells that are involved in causing kidney damage. In the study, it is given as a subcutaneous injection (under the skin) in a liquid solution. The purpose of including this antibody in the trial is to see whether it can safely reduce harmful immune responses that lead to antibody‑mediated kidney disease.

surovatamig is a new experimental drug being tested for its ability to treat antibody‑mediated kidney disease. It is administered by injection under the skin as a liquid solution. The trial is looking at whether surovatamig is safe for patients, how well they can tolerate it, and whether it can lower the amount of protein that leaks into the urine (proteinuria), which is a sign of kidney injury. The overall goal is to determine if surovatamig can improve kidney health in adults with this condition.

Antibody-mediated kidney disease – Antibody-mediated kidney disease is a condition in which the immune system produces antibodies that target structures in the kidneys. These antibodies can cause inflammation and damage to the filtering units called glomeruli. Over time, the damage may lead to increasing amounts of protein leaking into the urine. The disease often develops gradually, with protein levels rising before other signs appear. As the condition continues, kidney function may become less stable, reflected by changes in blood tests. Monitoring of urine protein and kidney function helps to track its course.

Trial ID:

2025-524139-38-00

Protocol code:

D740FC00001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Surovatamig and Human IgG4 Kappa Monoclonal Antibody Against CD3 and CD19 in Adults with Antibody-Mediated Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?