A Study of CND261 for Patients with Active ANCA-Positive Vasculitis That Has Not Responded to Previous Treatments

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What is this study about?

This study is looking at a condition called ANCA-IgG-positive associated vasculitis, which is a disease where the body’s immune system attacks blood vessels, causing inflammation and damage to various organs. The study focuses on patients whose disease is still active and has not responded well to previous treatments. The treatment being tested is called CND261, which is a type of medicine given through a drip into a vein. This medicine works by helping certain immune cells called T-cells to target and destroy specific immune cells called B-cells that are involved in causing the disease. The medicine does this by connecting to two proteins on the surface of these cells, one called CD3 and another called CD20.

The purpose of this study is to find out if CND261 is safe and how well it works in treating patients with this type of vasculitis who have not gotten better with other treatments. The study will look at whether the treatment causes any side effects, particularly a reaction called Cytokine Release Syndrome, which happens when the immune system releases substances too quickly, and another reaction called Immune Cell Associated Neurotoxicity Syndrome, which can affect the nervous system. The study will also check if the treatment can reduce or eliminate certain antibodies in the blood called ANCA antibodies, which are linked to the disease. Specifically, the study will measure anti-PR3 antibodies in patients with one form of the disease called granulomatosis with polyangiitis and anti-MPO antibodies in patients with another form called microscopic polyangiitis.

The study is divided into two phases. In the first phase, a small number of patients will receive the treatment to check if it is safe. In the second phase, more patients will receive the treatment to learn more about safety and to see how well it works in reducing disease activity and the antibodies that cause the disease. During the study, patients will be monitored regularly for any side effects and to measure changes in their disease activity, blood tests, and quality of life. The study will track how long patients can stay off other disease-modifying medicines, whether they experience any flare-ups of their disease, and how their overall health and ability to perform daily activities change over time.

1 Initial treatment preparation

Your treatment will begin with the administration of CND261, which is a solution given through an intravenous infusion. This means the medication will be delivered directly into your vein over a period of time.

The medication is designed to target specific cells in your immune system called CD3 and CD20 cells, which play a role in your condition.

2 Treatment administration phase

You will receive CND261 through an intravenous infusion, which means the medication will be given through a needle inserted into a vein.

The specific dosage, frequency, and duration of your treatment will be determined based on the phase of the study and your individual response to the medication.

During this phase, you will be closely monitored for any reactions to the treatment.

3 Early monitoring period

For the first 28 days after your last dose of CND261, you will be monitored closely for specific side effects.

The medical team will watch for signs of Cytokine Release Syndrome, which occurs when your immune system releases substances too quickly into your blood. Symptoms may include fever, fatigue, or difficulty breathing.

You will also be monitored for Immune Cell Associated Neurotoxicity Syndrome, which can affect your nervous system and may cause confusion, difficulty speaking, or other neurological symptoms.

Any adverse events or serious adverse events related to the treatment will be documented and assessed during this period.

4 Week 5 assessment

At week 5, your condition will be assessed to determine your response to the treatment.

The medical team will evaluate whether you need additional medications called DMARDs (disease-modifying antirheumatic drugs) or if you can continue without them.

5 Week 8 evaluation

At week 8, several assessments will be performed to measure your response to treatment.

Your Birmingham Vasculitis Activity Score will be measured. This score helps assess how active your vasculitis is by evaluating symptoms and organ involvement.

The Vasculitis Damage Index will be checked to measure any permanent damage caused by the disease.

Your blood will be tested to check the levels of anti-PR3 antibodies (if you have granulomatosis with polyangiitis) or anti-MPO antibodies (if you have microscopic polyangiitis). These are proteins in your blood that are associated with your condition.

The number of CD20+ B cells in your blood will be measured. These are immune cells that the medication targets.

Your eGFR (estimated glomerular filtration rate), which measures how well your kidneys are working, will be assessed.

Your CRP (C-reactive protein) levels will be checked. This is a marker of inflammation in your body.

You will complete questionnaires about your disease activity, quality of life, and physical function.

6 Week 12 evaluation

At week 12, similar assessments to week 8 will be repeated.

Your Birmingham Vasculitis Activity Score and Vasculitis Damage Index will be measured again.

Blood tests will be performed to check antibody levels, B cell counts, kidney function, and inflammation markers.

You will complete questionnaires about your symptoms and quality of life.

7 Week 24 evaluation

At week 24, a comprehensive evaluation will be conducted.

The medical team will determine if you have achieved ANCA seroconversion, which means your anti-PR3 or anti-MPO antibody levels have returned to normal ranges.

Your Birmingham Vasculitis Activity Score and Vasculitis Damage Index will be assessed.

All blood tests, including antibody levels, B cell counts, immunoglobulin levels (IgG, IgA, IgM), kidney function, and inflammation markers, will be repeated.

You will complete questionnaires about your disease activity, quality of life, and physical function.

8 Ongoing monitoring through week 52

Between week 5 and week 52, you will be monitored for any disease flares or relapses. A flare means your symptoms have returned or worsened.

The medical team will track the total amount of steroid medication you receive during this period.

Your need for DMARD therapy will be assessed throughout this time.

Regular blood tests will continue to monitor your antibody levels, B cell counts, immunoglobulin levels, kidney function, and inflammation markers.

9 Week 52 final evaluation

At week 52, a final comprehensive evaluation will be performed.

The medical team will assess whether you have achieved sustained remission, which means you have no signs, symptoms, or other features of active vasculitis.

Your Birmingham Vasculitis Activity Score and Vasculitis Damage Index will be measured.

Blood tests will be performed to check antibody levels, B cell counts, immunoglobulin levels, kidney function, and inflammation markers.

You will complete questionnaires about your disease activity, quality of life, and physical function.

The total number of flares you experienced, the duration you remained without DMARD therapy, and the cumulative steroid dosage will be calculated.

10 Extended safety monitoring

After week 52, you will continue to be monitored for any adverse events or serious adverse events until the end of the study.

All side effects will be documented, including their type, severity, seriousness, and relationship to the study medication.

Who Can Join the Study?

You must understand and willingly sign a consent form that explains the study
You must be 18 years of age or older at the time you agree to join the study
You must be able to follow the study schedule and requirements
You must meet the medical classification requirements for either granulomatosis with polyangiitis (a type of blood vessel inflammation affecting small vessels) or microscopic polyangiitis (another type of small blood vessel inflammation) according to 2022 medical guidelines
You must have positive blood test results for specific antibodies (proteins made by your immune system) called either anti-PR3 or anti-MPO that are above the normal level at the screening visit
You must have had a Birmingham Vasculitis Activity Score (a measurement tool that shows how active your blood vessel inflammation is) of at least 3 within the past 12 months before screening
Your condition must not have improved enough with previous treatments, or you could not tolerate those treatments. This means you must have tried at least three months of treatment with at least two of these medications: rituximab, mycophenolate mofetil, azathioprin, methotrexate, cyclophosphamide, avacopan, or glucocorticoids. Or you must have tried at least six weeks of combined treatment with cyclophosphamide or plasmapheresis (a procedure that filters your blood) together with rituximab. In some cases, you may join if your doctor believes rituximab treatment is not suitable for you due to medical reasons
If you are a male participant who has not had surgery to prevent fathering children, you must agree to use two birth control methods (such as spermicide and condom) during the study and must not father a child from the time you sign the consent form until 12 months after receiving the study treatment
If you are a female who can become pregnant, you must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time you sign the consent form throughout the entire study
You must have an updated vaccination record following the recommended guidelines for people with weakened immune systems

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate
However, patients must have active, treatment refractory, ANCA-IgG-positive associated vasculitis to be considered for this study, which means the disease must be currently causing symptoms, has not responded to standard treatments, and shows specific antibodies called ANCA-IgG in blood tests
Patients who do not meet these specific disease characteristics would not be eligible
The study accepts both male and female participants
Only adults and elderly patients can participate, meaning children and adolescents cannot take part in this study

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fyvmlvjhwj Ixramepjc Fmg Trvtornpyddrn Mvhlrapk Anf Pviqjcueoqxd Irls	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.12.2025

Trial locations

CD3/CD20 bispecific T-cell engager therapy is an experimental treatment being tested in this study. This medication works by connecting two types of cells in your body: T-cells (immune cells that can destroy other cells) and B-cells that have a marker called CD20 on their surface. By bringing these cells together, the medication helps your immune system target and remove the B-cells that may be contributing to your disease. This therapy is also referred to as CND261 in the study.

ANCA-Associated Vasculitis – ANCA-associated vasculitis is a group of diseases characterized by inflammation of blood vessel walls, associated with the presence of specific antibodies called ANCA (antineutrophil cytoplasmic antibodies). These antibodies mistakenly attack the body’s own cells, leading to damage of small and medium-sized blood vessels. The inflammation can affect various organs including the kidneys, lungs, skin, nerves, and joints. As the disease progresses, the affected blood vessels become damaged and narrowed, which reduces blood flow to the organs and tissues they supply. This can result in organ dysfunction and various symptoms depending on which parts of the body are affected. The disease can have periods of active inflammation (flares) alternating with periods of reduced or absent symptoms (remission).

Trial ID:

2025-522853-21-01

Protocol code:

TMP-05062025-1

Trial Phase:

Human Pharmacology (Phase I) – Other

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A Study of CND261 for Patients with Active ANCA-Positive Vasculitis That Has Not Responded to Previous Treatments

What is this study about?

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