Testing a new treatment for rheumatoid arthritis
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
This study is testing a new treatment using patients' own immune cells to see if it can help reduce inflammation and improve symptoms in people with moderate-to-severe rheumatoid arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sonoma Biotherapeutics, Inc. Industry-sponsored |
| Locations | 8 sites (Scottsdale, Arizona and 7 other locations) |
| Trial ID | NCT06201416 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effects of SBT777101, a novel regulatory T cell therapy, administered as a single dose to patients with moderate-to-severe rheumatoid arthritis. The approach involves using the patient's own Treg cells to target and reduce inflammation in affected tissues. The study will begin with lower doses to assess safety before escalating to higher doses. It represents the first human trial of this innovative treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate-to-severe rheumatoid arthritis who have not responded adequately to existing therapies.
Not a fit: Patients with uncontrolled comorbid conditions or other inflammatory joint diseases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of rheumatoid arthritis by reducing inflammation and restoring immune balance.
How similar studies have performed: While this approach is novel in humans, similar therapies targeting regulatory T cells have shown promise in preclinical studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 7 other locations
- Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
- UCSF Medical Center — San Francisco, California, United States (Recruiting)
- Stanford Medical Center — Stanford, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Tufts University — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Sabrina Fox-Bosetti, MPH
- Email: clinicaloperations@sonomabio.com
- Phone: 415-992-6245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.