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:

• Adults between 18 and 70 years old (inclusive), of any sex
• People who have previously been treated with a single-target CD19 or BCMA therapy that did not work, and who have waited at least 6 months since that last treatment
• People diagnosed with one of the following conditions, each with its own specific requirements (confirm details with trial site):
• Lupus (SLE): Diagnosed according to 2019 international classification criteria, with certain antibodies present in blood tests, a disease activity score of 8 or more on a standard scale, and at least 6 months of stable standard treatment that has not fully controlled the disease
• Systemic Sclerosis (SSc): Diagnosed according to 2013 international criteria, with a type that causes widespread skin thickening beyond the elbows and/or knees, lung involvement with lung function in a specific reduced range, and disease that has not responded to prior standard treatments including at least one immunosuppressive medicine taken for 6 months or more
• Inflammatory Muscle Disease (IIM): Specifically dermatomyositis, polymyositis, or immune-mediated necrotising myopathy, diagnosed according to 2017 international criteria, with measurable muscle weakness and active disease shown by several standard measures
• Sjögren's Syndrome (SS): Diagnosed according to 2016 international criteria, with a specific antibody (anti-Ro/SSA) present, some remaining saliva production measurable at screening, and an active disease score of 5 or more on a standard scale
• Autoimmune Haemolytic Anaemia (AIHA): Diagnosed according to Chinese national guidelines (2023), with blood test evidence of red blood cell breakdown, and disease that has relapsed or not responded to at least 3 months of corticosteroids combined with at least one immunosuppressive medicine and/or rituximab
• Multiple Sclerosis (MS): Diagnosed according to Chinese national guidelines (2023), with evidence of active disease shown by at least two of: a confirmed relapse in the past 12 months, new lesions on MRI, or measurable worsening of disability sustained for at least 6 months — and disease that has continued despite at least 12 months of disease-modifying treatment
• People who have tried corticosteroids and at least two other immunosuppressive or immune-modifying medicines at effective doses for at least 3 months, without adequate benefit
• People whose blood counts, liver, kidney, heart, and lung function meet specific minimum levels set by the trial (confirm exact values with trial site)
• People with an estimated life expectancy of more than 6 months
• People who agree to use effective contraception during treatment and for 24 months after receiving the CAR T-cell infusion; women who could become pregnant must have a negative pregnancy test at screening
• People who are able and willing to give written informed consent

Who may not be able to join:

• People who have or have had another active cancer, with limited exceptions for certain early-stage or fully treated skin cancers, cervical carcinoma in situ, localised prostate cancer treated with curative intent, or ductal carcinoma in situ after curative surgery where the person is considered cured or has been disease-free for at least 2 years
• People who have had severe lung disease in the past 3 months, including severely elevated pressure in the lung's blood vessels, or who need supplemental oxygen via a reservoir mask, or who require any form of mechanical breathing support at screening
• People whose blood levels of all three main antibody types (IgA, IgG, and IgM) are below the normal range at screening
• People who have received certain medicines within specific time periods before the study, including: B-cell-depleting therapies (such as medicines targeting CD19, CD20, CD22, CD52, CD38, or BCMA) within 1 month of screening if the treating doctor does not consider the therapy to have failed; high-dose intravenous immunoglobulin (IVIG) within 1 month of screening; high-dose corticosteroids within 24 hours before the preparatory treatment phase; very high-dose steroid pulses within 2 weeks; or specific medicines called telitacicept (within 2 weeks) or belimumab (within 3 weeks) before screening
• People who have had serious central nervous system (brain or spinal cord) disease or related symptoms in the past 6 months, such as brain inflammation, stroke, seizures, aphasia, or dementia (confirm with trial site)
• People who have had a severe lupus crisis in the 3 months before screening, such as severe organ involvement affecting the brain, blood, heart, lungs, liver, or blood vessels
• People with severe kidney disease, including severe lupus-related kidney disease within 8 weeks of screening defined by very high protein in urine or significantly reduced kidney function
• People with a known severe allergic reaction to any of the medicines used to prepare the body for CAR T-cell infusion, or to any component of the CAR T-cell manufacturing process
• People with active hepatitis B (with detectable virus in the blood), active hepatitis C (with detectable virus), syphilis with a specific blood test result, or HIV
• People with an uncontrolled fungal, bacterial, or viral infection, or any other infection the trial doctor considers makes participation unsafe
• People who have had a major organ transplant, such as a heart or lung transplant
• People with active tuberculosis or latent (inactive) tuberculosis detected by a skin test or blood test at screening, even without symptoms
• People who have had any of the following heart or blood vessel problems in the 6 months before screening: heart failure, heart attack, unstable chest pain, coronary artery procedures, certain serious heart rhythm problems, uncontrolled high blood pressure, or a history of hypertensive crisis
• People who have another autoimmune disease (other than the one being treated in this trial) that requires ongoing systemic treatment
• People with muscle disease caused by medication or a family history of HIV-associated muscle disease (for the IIM indication)
• People who are pregnant or breastfeeding
• People who have received a live vaccine within 6 weeks before the preparatory treatment phase of the trial
• People who have participated in another interventional clinical trial within the 3 months before signing consent, are currently receiving an experimental treatment, or plan to join another clinical trial during this study
• People with psychiatric conditions such as depression with suicidal thoughts or tendencies
• People who, in the trial doctor's judgement, have any other condition that makes participation unsuitable or unsafe

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