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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.