This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Experimental treatment
Mayo Clinic
Scottsdale, Arizona, United States
RECRUITINGUCSF Medical Center
San Francisco, California, United States
RECRUITINGStanford Medical Center
Stanford, California, United States
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Time frame: Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of dose-limiting toxicities (DLTs)
Death, CRS, ICANS, vital organ toxicity, hematological toxicity
Time frame: Day of treatment to end of DLT evaluation period (28 days)
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University of Colorado
Aurora, Colorado, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGTufts University
Boston, Massachusetts, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITING