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Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
NCT06201416 · Sonoma Biotherapeutics, Inc.
In plain English
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Official title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Enrollment target: 24 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-06
Estimated completion: 2026-03
Last updated: 2024-11-27
Interventions
Biological: SBT777101
Primary outcomes
- • 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))
Sponsor
Sonoma Biotherapeutics, Inc. · industry
Contacts & investigators
ContactSabrina Fox-Bosetti, MPH · contact · clinicaloperations@sonomabio.com · 415-992-6245
ContactAri Bitton · contact · clinicaloperations@sonomabio.com · 415-992-6245
InvestigatorJoseph Arron, MD · study_director, Sonoma Biotherapeutics, Inc.
All locations (8)
Mayo ClinicRecruiting
Scottsdale, Arizona, United States
UCSF Medical CenterRecruiting
San Francisco, California, United States
Stanford Medical CenterRecruiting
Stanford, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Tufts UniversityRecruiting
Boston, Massachusetts, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States