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:

• Adults aged 18 to 69 years old.
• People whose blood, liver, heart, and lung function are at adequate levels (as assessed by the trial site).
• Women who could become pregnant must have a negative pregnancy test at the start of the trial, and all people who could become pregnant must be willing to use a highly effective form of contraception for at least 12 months after treatment (at least 6 months for males).
• People who are willing and able to sign a consent form before joining.
• People who are able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.
• People with a confirmed diagnosis of Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), or Systemic Sclerosis (SSc), based on recognised classification guidelines and/or test results.
• People whose disease remains active despite having already tried standard treatments, including at least one immune-suppressing medication for at least 3 months (in addition to a medicine called hydroxychloroquine).

Who may not be able to join:

• People who currently have a significant bacterial, fungal, or viral infection that requires treatment, or who have a serious ongoing or recurring infection.
• People who have had an active cancer within the past 5 years, with some exceptions for certain types of well-treated skin cancers or low-risk prostate cancer (confirm with trial site).
• People who have previously received therapies targeting CD19 or CD70, or any prior engineered cell therapy such as CAR T-cell therapy.
• People who have another significant, unstable, or uncontrolled medical condition (such as an underactive thyroid or diabetes) that is not caused by their SLE, IIM, or SSc.
• People who have had serious heart or blood vessel problems requiring medical treatment within the 6 months before the trial, or who have certain heart-related fluid or electrical problems requiring medical intervention.
• People with moderate to severe liver scarring (cirrhosis classified as Child-Pugh Class B or C).
• People with significant breathing or airway problems requiring medical treatment, a large fluid build-up around the lungs, or a history of a blood clot in the lungs requiring blood-thinning medication within 6 months before joining.
• People who are known to not respond to blood or platelet transfusions, or who would refuse transfusions if needed to manage blood cell counts during treatment.
• People with an inherited immune system deficiency.
• People who are unwilling to participate in an extended safety monitoring period after treatment.
• For people with SLE: those who have had active disease affecting the brain or nervous system within the last 6 months, whose lupus was caused by a medication, or who have had certain levels of kidney scarring or required dialysis within the past 12 months (confirm specific kidney scoring details with trial site).
• For people with IIM: those whose muscle condition does not clearly fit the IIM classification, whose muscle weakness cannot be properly assessed, or those with a specific type of dermatomyositis involving a particular antibody called anti-TIF1 gamma.
• For people with SSc: those who have pulmonary arterial hypertension (high blood pressure in the lungs) requiring treatment, rapidly worsening or severe digestive system involvement, or a history of a kidney crisis related to scleroderma.

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