Study Details

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Allogenic CAR-T

This study is being done to find out if the study infusion, is safe and can help people with active autoimmune diseases. This study infusion has been used with patients with cancer, but this is the first time it will be given to people with autoimmune disorders. The doctors and staff running the study will know that you are receiving the study infusion. The main goal of this study is to first see if the study infusion is safe and figure out the right amount for patients.

Age & Gender

18 years ~ 70 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

If you join the study, the investigators will closely monitor your health and safety through exams and procedures. Some of these are part of the routine care you would receive even if you weren't in the study. Once the investigators confirm that you can receive the study drug, you will undergo chemotherapy. You will need to stay in the hospital for up to 7 days after receiving the study drug and follow ups after that for medical examinations and labs tests.

Incentives

Information provided upon request, Medical examination as part of the study

In-person visits:
~ 25

Total length of participation:
~ 5 years

Looking for Specific Volunteers

Able to participate:

Age ≥18 and ≤70 years of age.
Diagnosis of SLE by a board-certified rheumatologist
Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) or SSc interstitial lung disease (ILD)
Diagnosis with dermatomyositis (DM), polymyositis (PM)

Not eligible if:

Prior treatment with anti-CD19 therapy
Prior solid organ (e.g., heart, liver, kidney, lung) transplant
Positive for presence of human immunodeficiency virus type 1 or 2, history of hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
Pregnant or lactating

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Roger Huamani
roger_huamani@med.unc.edu

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, 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
Chronic Conditions
Genetics and Genetic Disorders
Hands and Feet
Immune System/Infections
Kidneys and Liver
Skin, Hair, and Nails

IRB Number

25-0324