Phase 1 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 aged 18 or older, of any gender.
• People whose blood tests (flow cytometry) show the presence of specific proteins called CD19 or BCMA on their B cells (a type of immune cell).
• People whose bone marrow, liver, and kidney functions meet certain minimum levels as measured by blood tests (with some exceptions allowed for abnormalities caused by the autoimmune disease itself — confirm with trial site).
• People with a general health/functioning score of 0–2 on a standard medical scale (meaning they are able to carry out at least some daily activities).
• People who are willing and able to use reliable contraception or abstain from sex during treatment and for at least 6 months afterward; women who could become pregnant must have a negative pregnancy test within 7 days before joining and must not be breastfeeding.
• People who are willing to participate, sign a consent form, and attend follow-up appointments.

For Systemic Lupus Erythematosus (SLE — a type of autoimmune disease):

• People with a confirmed SLE diagnosis meeting recognised international classification standards (2019 ACR/EULAR criteria).
• People with significantly active disease as measured by a standard scoring tool (SLEDAI-2000 score of 8 or higher), or with serious organ involvement such as active kidney inflammation confirmed by biopsy or significant protein in the urine.
• People whose SLE has not responded to at least 6 months of standard treatments (including steroids and one or more other immune-suppressing medicines or biologics), or whose disease came back after a period of improvement.

For Systemic Sclerosis (Scleroderma — a condition causing skin and organ hardening):

• People with a confirmed scleroderma diagnosis meeting recognised international criteria (2013 ACR criteria).
• People with positive blood antibodies associated with scleroderma.
• People who have widespread skin thickening or active lung scarring visible on a specialised CT scan.
• People whose condition has not responded to at least 6 months of standard treatments, or whose disease came back after improvement, OR whose disease is progressing rapidly (for example, significant worsening of skin or lung function within a short period).

For Inflammatory Myopathy (conditions causing muscle inflammation, including Dermatomyositis, Polymyositis, Anti-Synthetase Syndrome, and Necrotizing Myopathy):

• People with a confirmed diagnosis of one of these muscle inflammation conditions meeting recognised international criteria (2017 EULAR/ACR criteria).
• People with measurable muscle weakness on a standard physical test, plus at least two other signs of active disease found through standard assessments (confirm specific measurements with trial site).
• People whose condition has not responded to at least 6 months of standard treatments, or whose disease came back after improvement, OR whose lung disease associated with myopathy is progressing rapidly.

For ANCA-Associated Vasculitis (a group of conditions causing blood vessel inflammation):

• People with a confirmed diagnosis of microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis, meeting recognised international criteria (2022 ACR/EULAR criteria).
• People who test positive for specific antibodies associated with this condition (MPO-ANCA or PR3-ANCA).
• People with an active vasculitis activity score of 15 or more out of 63 on a standard medical scale (Birmingham Vasculitis Activity Scale).
• People whose condition has not responded to at least 6 months of standard treatments, or whose disease came back after improvement.

For Connective Tissue Disease-associated Thrombocytopenia (low platelet counts linked to autoimmune conditions):

• People with a confirmed connective tissue disease diagnosis (such as lupus, Sjögren's syndrome, antiphospholipid syndrome, or undifferentiated connective tissue disease).
• People with confirmed low platelet counts below a certain level (below 30 × 10⁹/L, or below 50 × 10⁹/L if there are signs of bleeding).
• People whose bone marrow results are consistent with immune-related low platelets.
• People who have already tried at least one course of high-dose steroid treatment, or steroids combined with one or more immune-suppressing medicines for at least 3 months, without achieving adequate improvement or without being able to maintain improvement when steroids are reduced.

Who may not be able to join:

• People with a history of severe allergic reactions to medicines, or a strong tendency toward allergies.
• People with an active infection (fungal, bacterial, viral, or other) that is not controlled or that requires treatment.
• People with brain or nervous system conditions caused by autoimmune or other diseases (such as epilepsy, psychosis, stroke, encephalitis, or central nervous system vasculitis).
• People with heart function that does not meet the minimum requirements for this study (confirm details with trial site).
• People born with an inability to produce immunoglobulins (a type of immune protein).
• People who have had a cancer diagnosis within the past five years.
• People with end-stage kidney failure (an exception may apply for certain kidney conditions linked to lupus — confirm with trial site).
• People who test positive for active hepatitis B, hepatitis C, HIV, or syphilis infections meeting certain blood test thresholds.
• People with significant psychiatric disorders or severe difficulties with thinking and memory.
• People who have taken part in another clinical trial within the past 3 months.
• People who have taken immune-suppressing medicines or biologics within a certain period before joining (based on how long each medicine stays active in the body — confirm timing with trial site).
• Women who are pregnant or planning to become pregnant.
• People whom the trial doctors consider unsuitable for other medical reasons.

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