Phase 1 Lupus Trial, Recruiting NCT07219563 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07219563
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:

  • People aged between 18 and 60 years old.
  • People who have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE or lupus), meeting a specific set of international diagnostic guidelines from 2019.
  • People whose medical records show certain positive blood test results, including a specific antibody test (ANA) at a level of 1:80 or higher, plus at least one other lupus-related antibody from a defined list (confirm with trial site for the full list of qualifying antibodies).
  • People whose lupus has not responded adequately to steroid treatment and at least two different types of immune-suppressing medications, including at least one advanced biological therapy or a specific chemotherapy drug called cyclophosphamide.
  • People whose lupus is currently active and scoring above a certain level of disease activity on standard medical measurement tools, but who have not had active lupus affecting the brain or nervous system within the past year (a small number of participants with only joint pain or skin rash as their main symptoms may also be considered if those symptoms are severely limiting daily life).

Who may not be able to join:

  • People who have another autoimmune disease in addition to lupus, unless it is a closely associated condition called Sjögren's disease that is not the main cause of their symptoms (people with fibromyalgia may still be considered if it is not their primary problem).
  • People with certain serious lupus complications, including a specific blood-clotting disorder, a severe form of kidney disease as the main qualifying reason, rapidly worsening kidney disease, kidney function below a certain level, or active lupus affecting the brain or nervous system.
  • People who have a current or suspected active infection, including HIV.
  • People whose blood test results or oxygen levels fall outside certain safe ranges, including low oxygen levels, low blood cell counts, low antibody levels in the blood, or abnormal liver test results (confirm with trial site for the specific numbers and thresholds).

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 27 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

Principal Investigator: Chrisanna Dobrowolski, MD, Icahn School of Medicine at Mount Sinai School

Phone: 212-241-1671

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
Registry
ClinicalTrials.gov
Start date
17 March 2026
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of treatment emergent AEs

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: 27 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