Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
- Registration Number
- NCT06201416
- Lead Sponsor
- Sonoma Biotherapeutics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Body mass index (BMI) <35 kg/m^2, inclusive
- Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
- Moderate-to-severe active disease
- Clinical and/or ultrasound evidence of synovitis
- Prior inadequate response to or unable to tolerate available RA therapies
- Stable doses of RA medications for at least 30 days
- Use of highly effective methods of contraception
- Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
- Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- Recurrent infections or active infection
- Active or untreated latent tuberculosis
- Primary or secondary immunodeficiency
- History of or current inflammatory joint disease other than RA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SBT777101 Dose 1 SBT777101 Low dose SBT777101 SBT777101 Dose 2 SBT777101 Mid dose SBT777101 SBT777101 Dose 3 SBT777101 High dose SBT777101
- Primary Outcome Measures
Name Time Method Incidence, nature, and severity of adverse events [Safety and Tolerability] Day of treatment to end of follow-up period (48 weeks) Incidence and nature of dose-limiting toxicities (DLTs) Day of treatment to end of DLT evaluation period (28 days) Death, CRS, ICANS, vital organ toxicity, hematological toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
UCSF Medical Center
🇺🇸San Francisco, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Stanford Medical Center
🇺🇸Stanford, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Tufts University
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States