Phase 1 Sjogren's Syndrome Trial, Recruiting NCT07041099 Sponsor: Cullinan Therapeutics Inc. Condition: Sjogren's Syndrome
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Phase 1 Sjogren's Syndrome Trial, Recruiting

NCT07041099
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have been diagnosed with Sjögren's disease (SjD) at least 24 weeks before your first study visit, and meet the standard 2016 classification criteria for this condition.
  • Your Sjögren's disease must be moderately to severely active at the time of screening, based on a specific disease activity score (ESSDAI of 5 or higher).
  • Your blood test results must meet certain minimum levels, including healthy enough counts for white blood cells, a specific type of immune cell called B cells, infection-fighting cells called neutrophils, red blood cells, and platelets, as well as acceptable levels for liver function and kidney function (confirm with trial site for exact values).

Who may not be able to join:

  • You have another rheumatic autoimmune disease in addition to Sjögren's disease.
  • You are considered to be at high risk of developing blood clots.
  • You have a rapidly worsening kidney condition involving the filtering units of the kidneys, or have high levels of protein leaking into your urine.
  • You have severe, active symptoms affecting your brain or spinal cord caused by Sjögren's disease.
  • You have a history of stroke, seizures, dementia, Parkinson's disease, Parkinson's disease, psychosis, paralysis, or any other significant neurological condition (confirm with trial site).
  • You currently have or have had an active infection with hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus.
  • You have a condition where your immune system does not work properly from birth, or you have had repeated serious infections in the past.
  • You have previously had your spleen removed.
  • You have received a live or weakened-live vaccine within 28 days before your screening visit or during the screening period.
  • You have had an active and significant infection of any kind — including COVID-19 — within 14 days before the trial starts.
  • You currently have active tuberculosis (TB) or have a latent (inactive) TB infection.

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +1 617 410 4650

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Cullinan Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
15 March 2028

Where this trial is recruiting

🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇺🇸 United States

Primary endpoints

Safety and Tolerability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov