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Breakfree-SLE

The goal of this research is to determine whether CAR T therapy is effective in treating participants with active Systemic Lupus Erythematosus (SLE), including those with Lupus Nephritis.

Age & Gender

  • 16 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Extended hours (M-F, early morning or evening)

Location

United States (Nationwide)

What will be asked of you

If you decide to take part in this research study, the general procedures include tests and exams to monitor your physical and mental well-being, collection of blood and urine samples, leukapheresis (a procedure to remove cells from your blood by a machine through two intravenous (IV) lines placed in your body), administration of pre-treatment drugs, study treatment given by IV infusion, hospital stay for the first 10 days after infusion (or outpatient, if applicable), and follow-up study visits.

Incentives

Information provided upon request, Study procedures covered by the study

In-person visits:
~28
Total length of participation:
up to 24 months

Looking for Specific Volunteers

Able to participate:

  • Active SLE including Lupus Nephritis
  • Inadecuate response to SLE treatment with glucocorticoids (GC), anti-malarial and at least 2 previous immunosuppressants

Not eligible if:

  • Prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant.
  • pregnant, nursing, or breastfeeding
  • Uncontrolled systemic infections

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Saira Sheikh
Thurston Arthritis Research Center

Study Type

Clinical or Medical
Interventional

Study Topics

Allergy
Bones, Joints, Muscles
Immune System/Infections
Skin, Hair, and Nails
Women's Health

IRB Number

25-0318

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