Phase 1 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:

• You are between 18 and 65 years old (inclusive).

• Your blood counts meet minimum levels — specifically, your infection-fighting white blood cells and red blood cells are above certain thresholds (confirm with trial site for exact values).

• Your liver is functioning well enough, based on blood test results within an acceptable range.

• Your kidneys are working at a sufficient level, based on a standard kidney function calculation.

• Your blood clotting ability is within an acceptable range.

• Your heart and circulation are stable.

• If you are able to have children, you agree to use an approved form of contraception (or abstain) during the trial and for at least 12 months after treatment ends.

• If you are a woman who could become pregnant, you have a negative pregnancy blood test within 7 days before joining, and you are not currently breastfeeding.

• You are willing to take part voluntarily and sign a consent form.

• You have been diagnosed with one of the following conditions that has not responded to standard treatments or has come back after treatment:

  • Lupus (SLE) — specifically with kidney involvement (lupus nephritis) or very low platelet counts (immune thrombocytopenia), confirmed by specific medical tests and after trying at least two standard treatments without enough improvement.
  • Sjögren's syndrome — confirmed by recognised diagnostic criteria, with a high disease activity score, a positive blood marker (anti-SSA/Ro), and disease that has continued or returned despite at least 6 months of standard treatment.
  • Systemic sclerosis (scleroderma) — confirmed by recognised criteria, with positive related antibodies, and either widespread skin hardening or active lung involvement, persisting or worsening despite standard treatment.
  • Inflammatory muscle disease (myositis) — such as dermatomyositis or polymyositis, confirmed by recognised criteria, with positive related antibodies and measurable muscle or lung involvement, persisting or worsening despite standard treatment.
  • ANCA-associated vasculitis — a type of blood vessel inflammation confirmed by recognised criteria, with positive related antibodies and a high disease activity score, persisting or returning despite standard treatment.
  • Antiphospholipid syndrome — confirmed by recognised criteria, with positive related antibodies on at least two separate tests, and clotting events that have returned despite standard blood-thinning treatment; or a severe ("catastrophic") form involving three or more organs.

Who may not be able to join:

• You have a history of serious allergic reactions to medicines, or you are known to have a highly allergic constitution.
• You have an active infection (bacterial, viral, fungal, or other) that is not currently controlled.
• You have a brain or nervous system condition that is not caused by your underlying disease (confirm with trial site).
• Your heart is not strong enough to safely tolerate the treatments used in this study.
• You were born with an immune system condition that causes you to lack certain antibodies (immunoglobulin deficiency).
• You have had a cancer diagnosis within the past 5 years.
• Your kidneys have reached end-stage failure.
• You have active hepatitis B, hepatitis C, HIV, or syphilis, based on specific blood test results.
• You have had a blood clot in a deep vein or in your lungs within the past 6 months before screening.
• You have a psychiatric disorder or severe memory/thinking difficulties.
• You have taken part in another clinical trial within the past 3 months.
• You have recently received certain immunosuppressive or biological medicines within a specific timeframe before joining (confirm exact timeframes with trial site).
• You are currently pregnant or planning to become pregnant.
• The trial doctor has identified another reason that means it would not be appropriate for you to join.

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