Early 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:

• People aged 18 to 65 years old at the time of signing the consent form.
• People with recurring or treatment-resistant Systemic Lupus Erythematosus (SLE) who have been diagnosed using recognised criteria, show certain positive antibody results, have already tried glucocorticoids with immunosuppressants and/or biologics for at least 3 months, and have a disease activity score of 8 or more during screening.
• People with recurring or treatment-resistant IgG4-Related Disease (IgG4-RD) who meet recognised classification criteria, have not responded to standard treatment, and have a specific pattern of disease involving the Mikulicz system (salivary and tear glands) (confirm with trial site).
• People with recurring or treatment-resistant Systemic Sclerosis (SSc) who meet recognised classification criteria, test positive for at least one relevant antibody, have a skin score of 10 or more, and have already tried glucocorticoids with immunosuppressants and/or biologics for at least 3 months without adequate response.
• People with recurring or treatment-resistant Idiopathic Inflammatory Myopathies (IIM) — including dermatomyositis, polymyositis, anti-synthetase syndrome, or necrotising myositis — who meet recognised criteria, test positive for at least one relevant antibody, meet certain disease activity measures during screening, have already tried standard treatments for at least 3 months, and have evidence of active muscle inflammation on biopsy or MRI.
• People with recurring or treatment-resistant ANCA-Associated Vasculitis (AAV) of the GPA or MPA subtype, who have not responded to standard treatments including glucocorticoids and immunosuppressants or rituximab for at least 3 months, currently or previously tested positive for AAV-related antibodies, and have a disease severity score of 3 or above.
• People whose major organ function (such as liver and kidneys) is assessed as sufficient by the trial team.
• People who agree to use effective contraception from the time of signing the consent form until one year after receiving the study treatment. Women of childbearing age must have a negative pregnancy blood test at screening and before receiving the treatment.
• People (or their legal guardian) who are willing to sign a consent form confirming they understand the study's purpose and procedures and agree to participate.

Who may not be able to join:

• People in the SLE group who had an uncontrolled lupus crisis within 8 weeks before screening and are assessed by the investigator as unsuitable to participate.
• People in the SLE group who have significant central nervous system conditions not caused by lupus — such as stroke, epilepsy, dementia, Parkinson's disease, or serious psychiatric illness — present before screening.
• People in the Systemic Sclerosis group who have high-risk pulmonary arterial hypertension (high blood pressure in the lung arteries), as defined by Chinese clinical guidelines (confirm with trial site).
• People who have previously had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant.
• People who experienced significant bleeding (Grade 2 or above) within 30 days before screening and are assessed by the investigator as unsuitable for enrolment.
• People who received a live vaccine against an infectious disease within 8 weeks before the infusion.
• People who have previously received treatment using a specific type of virus called vesicular stomatitis virus G (VSVG) pseudotype virus.
• People who have had thoughts of suicide within 6 months before signing the consent form, or any suicidal behaviour within 12 months before signing the consent form, where the investigator considers there to be a significant risk.
• Women who are pregnant or breastfeeding.
• People with a history of severe or uncontrolled disease of the liver, stomach or gut, kidneys, lungs, heart, or serious psychiatric or neurological conditions, or any other serious medical condition that the investigator believes could affect the person's safety or the study results.
• People who have had a malignant (cancerous) tumour in the 3 years before screening — except those who completed curative treatment with no known active disease for at least 3 years before enrolment, or those who have been fully treated for non-melanoma skin cancer with no current evidence of disease.
• People who received B-cell depleting biologic therapies (such as rituximab, ocrelizumab, or similar medicines) within 3 months before the infusion, unless tests show that B-cells have recovered.
• People who received immunosuppressant medicines or certain small molecule drugs within 3 days before the infusion.
• People who participated in another clinical research drug study within 4 weeks before the infusion (some exceptions may apply — confirm with trial site).
• People who received a live vaccine or live therapeutic infectious pathogen within 2 weeks before the infusion.
• People with active or chronic hepatitis B (unless viral levels are below a specified threshold), hepatitis C, HIV, or syphilis.
• People who currently have an active infection requiring intravenous antibiotics or hospitalisation.
• People who had major surgery (other than for diagnosis or biopsy) within 4 weeks before the infusion, or who are expected to need major surgery during the study. Note: procedures under local anaesthetic, kyphoplasty, and vertebroplasty are not considered major surgery.
• People with significant heart disease, including very high NT-proBNP levels, severe heart failure (Class III or IV), or a history of unstable angina, heart attack, coronary stent placement, or coronary bypass surgery within 6 months before the first dose.
• People with a known allergy, sensitivity, or intolerance to any component of the study drug (V001-BCMA), or who have previously had a severe allergic reaction.
• People who the investigators consider otherwise unsuitable for receiving the infusion or participating in the study.

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