Status:
RECRUITING
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Sonoma Biotherapeutics, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 dos...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06201416
Start Date
March 6 2024
End Date
March 1 2026
Last Update
November 27 2024
Active Locations (8)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
UCSF Medical Center
San Francisco, California, United States, 94143
3
Stanford Medical Center
Stanford, California, United States, 94305
4
University of Colorado
Aurora, Colorado, United States, 80045