BreakFree - CAR-T study in SLE, IIM and SSc

24-0289

• Adult women or men (age 18 and above) with confirmed, active SLE, IIM, SSc
• Fulfilling the 2013 EULAR/ACR classification criteria for probable or definite SSc.
• Antinuclear Antibody (ANA) positive at screening or prior to screening
• with diffuse cutaneous SSc meeting the following criteria: Disease duration ≤ 5 years (from onset of first non-Raynaud manifestation) AND mRSS ≥ 15 at screening AND mRSS increase ≥ 3 units or involvement of 1 new body area, or mRSS increase ≥ 2 units in 1 body area over 6 months AND At least one: C-reactive protein ≥ 10·0 mg/L, erythrocyte sedimentation rate ≥ 28 mm/h, OR Health Assessment Questionnaire – Disability Index (HAQ-DI) > 1.0
• Or participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD on HRCT and ≤ 5 years duration (from onset of first non-Raynaud manifestation) 
• AND inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or IVIG.
• Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren’s syndrome are not excluded.

Mario Farag

303-724-8948

CONQUER

Kristen Demoruelle, MD, PhD

Eligibility:

• Diagnosed with SSc, with first non-Raynaud's symptoms occurring in the last 5 years.

Primary contact:

[email protected]

303-724-7954