Phase 2 Sjogren's Syndrome 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:

For people with Refractory Lupus Nephritis (LN):

• People aged 10–65 of any gender whose lupus nephritis has not responded to at least one standard immune-suppressing treatment (such as steroids or cyclophosphamide) over 3–6 months, with protein in the urine not improving or worsening, and persistent positive autoantibodies
• People diagnosed with active, proliferative lupus nephritis confirmed by kidney biopsy, meeting specific classification types (Class III, IV, or combined III/IV with V — confirm exact class with trial site)
• People who meet the 2019 ACR/EULAR classification criteria for Systemic Lupus Erythematosus
• People with a positive ANA blood test result (titer of 1:80 or higher) and/or a positive anti-dsDNA antibody test at screening
• People whose blood tests show CD19+ B cells present, and who have stopped immune-suppressing medications for more than one week
• People with a lymphocyte (a type of white blood cell) count above 0.5×10⁹/L and no medical reason preventing blood cell collection
• People with no serious allergy history
• People with an ECOG performance score of 0–2 (meaning able to carry out normal daily activities or only mildly limited — confirm with trial site)
• People whose life expectancy is at least 90 days
• People (and/or their guardian, where applicable) who are able to understand and sign the informed consent form

For people with Systemic Sclerosis (SSc):

• People aged 18–65 of any gender
• People who meet the ACR/EULAR classification criteria for SSc, with a score of 9 or higher
• People who have thickened skin on the fingers of both hands extending beyond the knuckle joints
• People with a lymphocyte count above 0.5×10⁹/L and no medical reason preventing blood cell collection
• People (or their legal representative) who are able to sign the informed consent form

For people with Primary Sjögren's Syndrome with Pulmonary Arterial Hypertension (pSS-PAH):

• People aged 18–65 of any gender
• People diagnosed with primary Sjögren's syndrome according to recognised 2002 or 2016 classification criteria
• People whose pulmonary arterial hypertension (high blood pressure in the lung arteries) has been confirmed by a right heart catheterisation procedure, meeting specific pressure measurement thresholds (confirm details with trial site)
• People classified as low-risk for their pulmonary arterial hypertension, based on heart function grading, walking test results, and specific blood and pressure measurements (confirm details with trial site)
• People who have been on stable standard treatment for at least the required periods before starting the study drug, including steroids, antimalarial drugs, single immune-suppressing agents, and PAH-targeted medications (confirm specific drugs and doses with trial site)
• People whose treating doctor has assessed that they are suitable to reduce steroids to a low dose and stop most immune-suppressing medications (except hydroxychloroquine)
• Women of childbearing age with a negative blood pregnancy test within 7 days before the preparatory treatment
• All participants of childbearing potential who agree to use effective contraception throughout the study and for at least one year after the cell infusion
• People with sufficiently normal liver function and lung function, including blood oxygen levels above 95% without supplemental oxygen (confirm specific lab value thresholds with trial site)
• People with a lymphocyte count above 0.5×10⁹/L and no medical reason preventing blood cell collection
• People (or their legal representative) who are able to sign the informed consent form

For people with Autoimmune Disease (AID) not fitting the above three groups:

• People aged 10–65 of any gender who do not fully meet the criteria for the three groups above but meet at least one of the following
• People with a low or negative ANA or anti-dsDNA result at screening (confirm thresholds with trial site)
• People who have had repeated infections during standard treatment that have made continuing that treatment not tolerable, with no current active or serious infection (such as tuberculosis)
• People who can no longer take their medications due to bone damage (such as bone death or severe bone pain) caused by long-term drug use
• People who can no longer take their medications due to eye problems (such as vision changes or bleeding at the back of the eye) caused by long-term drug use
• People who can no longer take their medications due to hormone-related effects (such as severe obesity, diabetes, or effects on growth and development) caused by long-term drug use
• People with severe blood cell count abnormalities meeting specific thresholds (confirm with trial site)
• People with abnormal liver function test results meeting specific thresholds (confirm with trial site)
• People whose disease has continued to get worse after 3 months of regular treatment (for example, a threefold rise in urine protein levels)
• People who have previously received CAR-T therapy but whose disease has continued to progress

Who may not be able to join:

For people with Refractory Lupus Nephritis (LN):

• People with raised pressure in the brain or a reduced level of consciousness
• People with symptomatic heart failure or a serious irregular heartbeat
• People with severe breathing failure
• People with another type of cancer
• People with a serious blood clotting disorder called diffuse intravascular coagulation
• People with sepsis (severe bloodstream infection) or another uncontrollable infection
• People with uncontrolled diabetes or other uncontrolled hormonal/glandular conditions
• People with a severe mental health condition
• People with active brain lesions detected on an MRI scan
• People who have previously had an organ transplant (bone marrow transplants are not excluded)
• Women of childbearing age with a positive blood pregnancy test
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People from whom blood cells cannot be collected and for whom no stored cells are available for making the CAR-T treatment
• People with significantly reduced kidney function below a specific threshold (confirm with trial site)
• People with certain active skin conditions that could interfere with lupus assessment, including psoriasis, dermatomyositis, systemic sclerosis, or drug-induced lupus (confirm full list with trial site)
• People who have previously received a CAR-T therapy other than CD19-targeted CAR-T

For people with Systemic Sclerosis (SSc):

• People with another connective tissue disease such as Rheumatoid Arthritis, Systemic Lupus, or Inflammatory Myopathies
• People whose symptoms can be explained by a condition that resembles SSc but has a different cause (confirm specific conditions with trial site)
• People with severe active central nervous system lupus requiring treatment in the 60 days before the baseline visit, including seizures, psychosis, stroke, or brain blood vessel inflammation
• People on dialysis or with kidney function below a specific threshold (confirm with trial site)
• People who are pregnant or breastfeeding
• People with an active serious infection such as sepsis, uncontrolled lung infection, or active tuberculosis
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who have had major surgery within 4 weeks before screening, where the trial investigators consider enrolment unsuitable
• People who have previously received a CAR-T therapy other than CD19-targeted CAR-T

For people with pSS-PAH:

• People whose pulmonary hypertension is caused by another condition such as portal hypertension, congenital heart disease, chronic lung disease, or chronic blood clots in the lungs (confirm full list with trial site)
• People with severe active central nervous system lupus requiring treatment in the 60 days before the baseline visit, including seizures, psychosis, stroke, or brain blood vessel inflammation
• People on dialysis or with kidney function below a specific threshold (confirm with trial site)
• People who are pregnant or breastfeeding
• People with an active serious infection such as sepsis, uncontrolled lung infection, or active tuberculosis
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who have had major surgery within 4 weeks before screening, where the trial investigators consider enrolment unsuitable
• People who have previously received a CAR-T therapy other than CD19-targeted CAR-T

For people with Autoimmune Disease (AID):

• People with raised pressure in the brain or a reduced level of consciousness
• People with symptomatic heart failure or a serious irregular heartbeat
• People with severe breathing failure
• People with another type of cancer
• People with a serious blood clotting disorder called diffuse intravascular coagulation
• People with sepsis or another uncontrollable infection
• People with uncontrolled diabetes or other uncontrolled hormonal/glandular conditions
• People with a severe mental health condition
• People with active brain lesions detected on an MRI scan
• People who have previously had an organ transplant (bone marrow transplants are not excluded)
• Women of childbearing age with a positive blood pregnancy test
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People from whom blood cells cannot be collected and for whom no stored cells are available for making the CAR-T treatment
• People with significantly reduced kidney function below a specific threshold (confirm with trial site)

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