Phase 2 Lupus 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 who are 18 years of age or older at the time of signing the consent form
• People who are able to understand the study and are willing to sign a consent form, including consent for their data to be used
• People whose kidneys, liver, heart, and lungs are functioning above a minimum level (the trial site will assess this through tests)
• Male participants who are not surgically sterile must agree to use two forms of contraception during the trial and for 12 months after receiving the study treatment
• Female participants who could become pregnant must have a negative pregnancy test at the start of the study and must agree to use a highly effective form of contraception during the trial and for 12 months after receiving the study treatment
• People who are able to attend all required study visits and follow the study plan
• People who have received at least two COVID-19 (SARS-CoV-2) vaccinations, or one vaccination within the last 6 months

For people with Systemic Lupus Erythematosus (SLE — a condition where the immune system attacks the body's own tissues):

• People whose condition meets the internationally recognised 2019 classification criteria for SLE
• People whose blood tests show certain specific antibodies associated with SLE
• People whose SLE is currently active, meaning at least one body system is severely affected or at least two body systems are moderately affected (assessed using a standard medical scoring tool)
• People whose SLE has not responded well enough, or who cannot tolerate or take, steroid treatment and at least two of the following medicines: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab, or cyclophosphamide

For people with Systemic Sclerosis (SSc — a condition involving hardening and tightening of the skin and connective tissues):

• People whose condition meets the internationally recognised 2013 classification criteria for SSc
• People whose blood tests show at least one specific antibody associated with SSc
• People showing signs that their condition is progressing quickly, including factors such as: the condition having started within the last 5 years, specific skin-thickening scores falling within a certain range, elevated inflammation markers in blood tests, or measurable worsening of skin involvement over 6 months (the trial site will assess these details)
• People whose SSc has not responded well enough, or who cannot tolerate or take, at least two of the following medicines: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, or rituximab

For people with Dermatomyositis or Polymyositis (DM/PM — conditions causing muscle inflammation and weakness):

• People whose condition meets the internationally recognised 2017 classification criteria for probable or definite DM or PM
• People who have evidence of active muscle inflammation (shown on a muscle biopsy or MRI scan) and/or signs of related lung disease
• People whose blood tests show at least one specific antibody associated with myositis (muscle inflammation)
• People with a measurable level of muscle weakness, assessed using standard scoring tools, along with at least two additional indicators of disease activity (the trial site will assess these details)
• People whose DM/PM has not responded well enough, or who cannot tolerate or take, steroid treatment and at least two of the following medicines: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, or intravenous immunoglobulins

Who may not be able to join:

• People for whom the treating doctor considers a less intensive or already-approved treatment to be a suitable option
• People whose blood cell counts or red blood cell levels fall below certain minimum levels (the trial site will check this through blood tests)
• People with another serious uncontrolled illness, such as cancer (other than certain common skin cancers) or uncontrolled diabetes
• People whose kidney, liver, heart, or lung function is severely reduced below the minimum levels required for the trial
• People with any other condition or abnormal test result that the trial team believes would make participation unsafe or make it hard to interpret the study results
• People who have previously received anti-CD19 antibody therapy, adoptive T cell therapy, or any gene therapy including CAR T cell therapy
• People who have previously had a bone marrow, stem cell, or solid organ transplant
• People with a current serious active infection, including HIV, hepatitis B or C, active COVID-19, or active tuberculosis; people with latent (inactive) tuberculosis may be considered if appropriate treatment has already been started (confirm with trial site)
• People diagnosed with severe neuropsychiatric lupus, inclusion body myositis, or limited systemic sclerosis
• People who are pregnant or breastfeeding
• People who are planning to become pregnant during the study period
• People with a known allergy or sensitivity to any components of the study drug
• People who have had a cancer diagnosis in the 5 years before the screening visit
• People who need to receive a live vaccine during the study, or within 14 days before a procedure to collect immune cells (leukapheresis)
• People under 18 years of age, or people who are not able to understand the purpose and consequences of the study or give legal consent
• People with a history of alcohol or substance misuse in the 6 months before joining, if the trial team believes this could affect safety or the study results
• People who have a personal or family relationship with the study sponsor or investigators that could create a conflict of interest

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