Phase 2 Pulmonary Hypertension 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:

For Lupus Nephritis (LN):

• People aged 3 to 65 years old with lupus nephritis confirmed by a kidney biopsy (taken within 6 months before or during the screening period) showing active, proliferative disease of specific types (Type III, IV, or III/IV combined with V, excluding certain chronic subtypes)
• People who meet the 2019 ACR/EULAR classification standards for systemic lupus erythematosus
• People whose blood tests show a clearly positive antinuclear antibody (ANA) level of 1:80 or higher, and/or a positive anti-double-stranded DNA (anti-dsDNA) antibody result of 30 IU/mL or higher
• People who have measurable CD19+ B cells and who have stopped immunosuppressant medications for more than one week
• People with no history of severe allergic reactions
• People with a physical functioning score (ECOG) of 0, 1, or 2 — meaning they are able to carry out at least some daily activities
• People whose doctors expect them to survive for at least 90 days
• People (or their guardians) who are willing and able to sign an informed consent form

For Systemic Sclerosis (SSc):

• People aged 6 to 65 years old of any gender who (or whose legal representative) voluntarily agree to participate
• People who meet the 2013 ACR/EULAR classification criteria for systemic sclerosis, scoring 9 points or higher
• People whose skin on both hands has thickened and extends beyond the knuckles toward the wrist, which on its own may meet the classification standard for SSc

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

• People aged 18 to 65 years old of any gender who (or whose legal representative) voluntarily agree to participate
• People diagnosed with primary Sjögren's syndrome according to established classification criteria (2002 AECG or 2016 ACR/EULAR)
• People whose pulmonary arterial hypertension (high blood pressure in the lungs) has been confirmed by a right heart catheterisation procedure, meeting specific pressure and resistance measurements as defined in 2022 guidelines
• People whose PAH has not been classified as low risk — meaning their heart function, walking ability, heart strain markers, and heart pressures do not all fall within the low-risk range
• People who have been on a stable dose of standard treatment for at least the required period before the first study dose, including corticosteroids, certain immunosuppressants, and fewer than three types of PAH-targeted medications
• People whose doctors assess that corticosteroid doses can be kept at or below the equivalent of 10mg prednisone per day during the study, and that all immunosuppressants (except hydroxychloroquine) can be stopped
• Women of childbearing potential who have a negative blood pregnancy test within 7 days before treatment, and all people with the biological potential to have children who agree to use effective contraception throughout the study and for at least one year after the cell infusion
• People whose liver function blood tests fall within acceptable ranges, and whose blood oxygen level is above 95% without supplemental oxygen

Who may not be able to join:

For Lupus Nephritis (LN):

• People with raised pressure in the brain or reduced consciousness
• People with symptomatic heart failure or serious heart rhythm problems
• People with severe breathing difficulties
• People who also have another type of cancer
• People with a condition called diffuse intravascular coagulation (a serious blood clotting disorder)
• People with sepsis or other difficult-to-control infections
• People with uncontrolled diabetes or other uncontrolled hormonal/glandular conditions
• People with serious mental health disorders
• People whose brain MRI shows significant abnormalities
• People who have received an organ transplant (bone marrow transplant is not excluded)
• Women with childbearing potential whose blood pregnancy test (HCG) is positive
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People whose kidney filtration rate (eGFR) is below 30 mL/min/1.73m²
• People with active skin conditions that could interfere with lupus assessment, such as psoriasis, dermatomyositis, or drug-induced lupus
• People for whom a suitable cell match could not be found during screening
• People who have previously received a type of CAR-T cell therapy other than CD19-targeted CAR-T

For Systemic Sclerosis (SSc):

• People who have an overlapping connective tissue disease such as rheumatoid arthritis, systemic lupus erythematosus, or inflammatory muscle disease
• People whose symptoms can be explained by conditions that resemble SSc, such as certain skin-hardening or fibrotic disorders, graft-versus-host disease, or diabetes-related joint conditions
• People with severe active central nervous system (brain or spinal cord) involvement from lupus, including seizures, psychosis, or stroke, within 60 days before starting the study
• People on dialysis or whose kidney clearance rate is below 30 mL/min
• People who are pregnant or breastfeeding
• People with active serious infections such as sepsis, uncontrolled lung infections, or active tuberculosis
• People who test positive for hepatitis B (certain markers), hepatitis C, HIV, or syphilis
• People who have had major surgery within 4 weeks before screening that the research team considers makes participation unsuitable
• People for whom a suitable cell match could not be found during screening
• People who have previously received a type of CAR-T cell therapy other than CD19-targeted CAR-T

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

• People whose high lung blood pressure is caused by other reasons, such as portal hypertension, hereditary blood vessel conditions, congenital heart disease, chronic low oxygen levels, or blood clots in the lungs
• People with severe active central nervous system involvement, including seizures, psychosis, or stroke within 60 days before starting the study
• People on dialysis or whose kidney clearance rate is below 30 mL/min
• People who are pregnant or breastfeeding
• People with active serious infections such as sepsis, uncontrolled lung infections, or active tuberculosis
• People who test positive for hepatitis B (certain markers), hepatitis C, HIV, or syphilis
• People who have had major surgery within 4 weeks before screening that the research team considers makes participation unsuitable
• People for whom a suitable cell match could not be found during screening
• People who have previously received a type of CAR-T cell therapy other than CD19-targeted CAR-T

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