Phase 2 Vasculitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 80 years old (male or female).
• People whose blood tests show a protein called CD19 is present on certain immune cells (B cells).
• People diagnosed with a refractory autoimmune disease — meaning standard treatments have not worked for more than 6 months, or the disease came back after a period of improvement. Standard treatments include steroids and at least one other medication such as cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, rituximab, or similar drugs.
• People currently taking one or more standard treatments at a stable dose, including steroids, antimalarials, immunosuppressants, or biologics, with specific requirements around how long doses have been stable before joining (confirm with trial site for exact details).
• People who are able and willing to use approved contraception, or abstain from sex, during the study and for at least 6 months afterwards. For women who could become pregnant, a negative pregnancy blood test within 7 days before joining is required, and breastfeeding must not be occurring.
• People willing to take part in the trial and sign a consent form.

Disease-specific criteria — people with one of the following conditions may also need to meet additional requirements:

• Systemic Lupus Erythematosus (SLE): Diagnosed according to 2019 international classification criteria, with certain antibodies present in the blood and a disease activity score of 8 or higher on a standard scale (SLEDAI-2000).
• Sjögren's Syndrome: Diagnosed according to recognised international criteria, with a disease activity score of 5 or higher (ESSDAI), and a specific antibody (anti-SSA/Ro) present in the blood.
• Systemic Sclerosis (SSc): Diagnosed according to 2013 international criteria, classified as either limited or diffuse skin involvement, and either a skin scoring measure above 10 (mRSS) and/or active lung disease shown on imaging or breathing tests.
• Idiopathic Inflammatory Myopathies (IIM): Diagnosed according to 2017 international criteria (including dermatomyositis, polymyositis, antisynthetase syndrome, or necrotising myopathy), with specific muscle strength and disease activity measurements, and certain myositis-related antibodies present in the blood.
• ANCA-Associated Vasculitis (AAV): Diagnosed according to 2022 international criteria, with ANCA antibodies present (now or previously), and a vasculitis activity score of 15 or higher (out of 63) on a standard scale (BVAS).
• Antiphospholipid Syndrome (APS): Diagnosed according to 2023 international criteria, with medium-to-high levels of specific antibodies confirmed on at least two tests within 3 months, and disease that remains active or has returned despite at least 6 months of standard treatment including anticoagulants and/or steroids and immunosuppressants. A severe form called Catastrophic APS (CAPS) may also be considered if specific criteria are met (confirm with trial site).

Who may not be able to join:

• People with a history of serious drug allergies or a tendency toward severe allergic reactions.
• People with an active or suspected infection (fungal, bacterial, viral, or other) that is not controlled or requires treatment.
• People with diseases affecting the brain or central nervous system, whether caused by an autoimmune condition or not — including epilepsy, certain psychiatric conditions, stroke, encephalitis, or brain vasculitis.
• People whose bone marrow, liver, kidneys, blood clotting system, or heart are not functioning within the levels required by the trial — unless those abnormalities are directly caused by the autoimmune disease itself (confirm with trial site for specific lab values).
• People born with a condition causing a deficiency in immunoglobulins (certain immune proteins).
• People who have had a cancer diagnosis in the past five years.
• People with active or detectable hepatitis B virus, hepatitis C virus, HIV, or syphilis infections, based on specific blood test results.
• People with a psychiatric disorder or severe problems with thinking or memory.
• People who have participated in another clinical trial within the past 3 months.
• People who have previously received CAR-T cell therapy.
• People who have had severe reactions to the drugs cyclophosphamide or fludarabine in the past.
• People who, for any other reason, the trial investigators determine are not suitable to participate.

Important: Always verify eligibility with the trial site directly before applying.