Phase 1 Lupus Trial, Recruiting

Written by an AI model from the 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 69 years old.
• People who are willing to sign a consent form and follow all study requirements.
• People whose blood counts, kidneys, liver, heart, and lungs are functioning at an adequate level.
• People who agree to use acceptable methods of contraception during the study.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.
• People who have been diagnosed with one of the following conditions: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
• For lupus (SLE): People diagnosed by a specialist rheumatologist according to 2019 international guidelines. For those with lupus-related kidney disease, a specific type confirmed by kidney biopsy (Class III or IV, with or without Class V) is required.
• For systemic sclerosis (SSc): People diagnosed according to 2013 international guidelines, with either a widespread skin form or lung involvement, and with signs of active skin or lung disease.
• For inflammatory muscle disease (IIM): People diagnosed with dermatomyositis, polymyositis, myositis as part of an overlap condition, antisynthetase syndrome, or immune-mediated necrotizing myopathy, according to 2017 international guidelines, with moderate to severe muscle, skin, or lung involvement.

Who may not be able to join:

• People who have previously received anti-CD19 therapy, gene therapy, or any treatment involving genetically modified cells.
• People who have had a transplant of a solid organ (such as heart, liver, kidney, or lung) or a bone marrow/stem cell transplant.
• People with severe active or past involvement of the central nervous system (brain and spinal cord) from their condition.
• People with a history of seizure disorders, stroke, dementia, cerebellar disease, or any autoimmune condition affecting the brain or nervous system other than the qualifying diagnoses.
• People diagnosed with mixed connective tissue disease where no single condition is clearly the main diagnosis.
• People whose disease features or other health conditions are likely to create significant safety risks or make it difficult to assess the effects of the treatment (confirm with trial site).
• People with a history of primary or secondary immune deficiency disorders.
• People with certain active or past bacterial, viral, or fungal infections (confirm with trial site for specifics).
• People who have had a cancer diagnosis in the last 5 years, unless the cancer is considered very unlikely to return.
• People with a genetic disorder linked to bone marrow failure or a condition called myelodysplastic syndrome.
• People with a history or current diagnosis of catastrophic antiphospholipid syndrome, or antiphospholipid syndrome that requires ongoing blood-thinning medication.
• People who are pregnant or breastfeeding.
• People with other conditions or treatments that are not compatible with the study protocol (confirm with trial site).

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