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Recruiting Phase 1 NCT06201416

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Phase 1 – testing safety in a small group of people
Conditions: Rheumatoid Arthritis

Sponsor: Sonoma Biotherapeutics, Inc.

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
SBT777101
BIOLOGICAL
Locations 8
United States (8)
University of Colorado
Aurora , Colorado
Tufts University
Boston , Massachusetts
Massachusetts General Hospital
Boston , Massachusetts
Brigham and Women's Hospital
Boston , Massachusetts
Northwestern University
Chicago , Illinois
UCSF Medical Center
San Francisco , California
Mayo Clinic
Scottsdale , Arizona
Stanford Medical Center
Stanford , California
Uma Vilas Ayachit
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
06.03.2024
Completion date
01.11.2026
Registry ID
NCT06201416
Source
clinicaltrials.gov
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