Early Phase 1 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 aged 5 years or older, of any gender
• People (or their legal guardian) who agree to take part and sign a consent form after being fully informed about the trial
• People whose blood tests confirm that their B cells (a type of immune cell) carry a marker called CD19, with enough of these cells present in the blood
• People who have previously received treatment that targets B cells, where blood tests at screening show B cell counts have returned to normal or pre-treatment levels
• People whose heart scan (echocardiogram) shows basically normal heart structure and function (with the heart pumping at least 55% of its capacity), and whose heart electrical test (ECG) shows no major concerns
• People whose liver test results are within an acceptable range (confirm specific values with trial site)
• People whose kidneys are filtering blood at an acceptable rate (confirm specific threshold with trial site); people with lower kidney function may still be considered if the treating doctor judges the benefit outweighs the risk
• People whose lungs are working adequately, with blood oxygen levels of 92% or above, and no severe lung damage
• Women who could become pregnant must have a negative pregnancy test and agree to use effective contraception during the trial and for 1 year after receiving the treatment

Additional criteria depending on the specific condition:

Polyarticular Juvenile Idiopathic Arthritis (a type of childhood arthritis affecting many joints):

• Diagnosed with this specific type of childhood arthritis before age 16, with symptoms lasting at least 6 weeks, and with certain antibodies (RF and/or ACPA) detected on at least 2 occasions at least 3 months apart within the first 6 months of illness
• The treating doctor judges the disease is still active despite having tried adequate standard treatment — including at least 6 months on standard arthritis medicines (with stable doses for at least 12 weeks), and at least 2 biological medicines (with stable doses for at least 12 weeks)
• A specific arthritis disease activity score (JADAS-27) above 8.5 at the time of screening
• At least 5 joints that are actively inflamed (swollen, or with limited movement plus pain or tenderness) at both the screening and baseline visits
• No episode of a serious immune complication called macrophage activation syndrome in the month before screening

Sjögren's Syndrome (a condition affecting moisture-producing glands):

• Diagnosed with childhood-onset primary Sjögren's Syndrome at least 24 weeks before signing the consent form, using recognised international classification criteria
• Has not responded well enough to, or cannot tolerate, steroid treatment and at least 2 medicines that suppress the immune system, with steroid treatment lasting at least 6 months
• A specific disease activity score (ESSDAI) of 5 or above in at least one of eight body system areas at screening
• A patient-reported symptom score (ESSPRI) of 5 or above at screening
• A specific antibody called anti-SSA/Ro is present in the blood

Juvenile Dermatomyositis (a childhood inflammatory muscle and skin disease):

• Diagnosed with juvenile dermatomyositis at least 24 weeks before signing the consent form, using recognised international criteria
• Disease is considered treatment-resistant, with inadequate response to or intolerance of steroid treatment and at least 2 immune-suppressing medicines, with steroid treatment lasting at least 6 months
• People with a related condition called anti-synthetase syndrome who are antibody positive and meet the treatment-resistant criteria may also be considered
• People with a related condition called immune-mediated necrotising myopathy who carry specific antibodies (SRP or HMGCR) and meet the treatment-resistant criteria may also be considered

Systemic Sclerosis (a condition causing hardening of the skin and other tissues):

• Diagnosed with systemic sclerosis using recognised 2013 international criteria, with the first non-Raynaud's symptoms starting before age 18 and disease duration of 60 months or less
• Certain antibodies are present in the blood (ANA or other SSc-specific antibodies)
• A skin thickness score (mRSS) of 15 or above (out of a total of 51)
• Disease has not responded adequately to steroid treatment, cyclophosphamide, and at least one other immune-modifying medicine, each taken for more than 3 months
• People diagnosed with a treatment-resistant form of undifferentiated connective tissue disease with lung involvement (UCTD-ILD) may also be considered, where symptoms such as cough or breathlessness have not improved after at least 1 month of steroid treatment (confirm details with trial site)

Systemic Lupus Erythematosus (SLE, also called lupus):

• Diagnosed with childhood-onset lupus using recognised international classification criteria
• Has tried steroid treatment (at a specified dose) combined with one or more immune-modifying medicines for at least 3 months; or cannot tolerate standard treatment and the treating doctor judges benefit outweighs risk; or has been unable to reduce steroid doses to a low level after 6 months of standard treatment
• A specific lupus disease activity score (SLEDAI-2K) above 6
• No episode of a serious immune complication called macrophage activation syndrome in the month before screening

Mixed Connective Tissue Disease (MCTD):

• Diagnosed with childhood-onset primary MCTD at least 24 weeks before signing the consent form, using recognised classification criteria adapted for children
• Has not responded well enough to, or cannot tolerate, steroid treatment and at least 2 standard immune-suppressing medicines, with steroid treatment lasting at least 6 months
• A specific MCTD disease activity score (MDAI) of 8 or above at screening
• A patient-reported outcome score for MCTD-related symptoms of 5 or above at screening
• A specific antibody called anti-U1-RNP is present at high levels in the blood, and another antibody called anti-Sm is not present

Who may not be able to join:

• People who have or have had cancer, with some exceptions for certain skin cancers or cervical changes that were fully treated and cleared at least 5 years ago
• People with a known allergy, sensitivity, or intolerance to the trial treatment (CD19/BCMA CAR-NK cells) or to any medicines that may be used during the trial, including fludarabine, cyclophosphamide, or tocilizumab, or who have had a severe allergic reaction in the past
• People with serious active bacterial or viral infections, or uncontrolled fungal infections, at the time of screening or the start of the trial, or who need intravenous antibiotics for an uncontrolled infection
• People with significant heart failure (classified as Class III or IV by a standard medical rating system)
• People with congenital heart disease, a heart attack within the past 6 months, serious heart rhythm problems, significant fluid around the heart, severe heart muscle inflammation, or unstable vital signs requiring medicines to maintain blood pressure
• People who test positive for active hepatitis B virus, hepatitis C virus, HIV, syphilis, or cytomegalovirus (CMV) in blood tests at screening (confirm specific testing thresholds with trial site)
• People with a history of severe herpes infections (such as herpes affecting the brain or eyes), or who have shown signs of herpes or chickenpox/shingles infection within 12 weeks before screening
• People with active tuberculosis, a history of active tuberculosis, or who cannot produce a negative tuberculosis blood test result during screening
• People with a lung condition called interstitial lung disease (ILD) who meet certain severity thresholds — including very low lung function test results, needing ongoing oxygen therapy, having had a serious flare or hospitalisation in the past 6 months, or having rapidly worsening ILD as judged by the treating doctor
• People with pulmonary arterial hypertension (high blood pressure in the lung blood vessels) who meet certain severity thresholds — including high pressure readings on heart scans, severe functional classification, recent hospitalisation due to a flare, or needing certain intravenous medicines (confirm specific thresholds with trial site)
• People with a history of epilepsy or other active central nervous system diseases
• People with any condition that causes a weakened immune system, whether present from birth or acquired
• People with any significant ongoing medical condition in areas such as the heart, liver, kidneys, lungs, nervous system, blood, or mental health that the treating doctor judges would make it unsafe to receive the trial treatment
• People who have had an organ transplant or stem cell transplant within the past 3 months, or who have had a significant graft-versus-host disease reaction within the past 2 weeks
• People who received a live vaccine within 4 weeks before screening
• People who have received certain specific treatments within defined time periods before the trial baseline visit — including B cell depletion therapy within the past 26 weeks, certain biological medicines within the past 24 weeks, certain targeted medicines (such as JAK inhibitors) within the past 12 weeks, certain traditional herbal medicines within the past 4 weeks, or other prior therapies where effects have not yet fully worn off (confirm specific medicines and timeframes with trial site)
• People who have participated in another clinical trial within the past 3 months
• People whom the treating doctor considers to be at increased risk or who may affect the reliability of the trial results for any other reason

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