Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

NCT06201416 · tracked via the Priya Life Science USA tracker

Sponsor

Sonoma Biotherapeutics, Inc.

Phase

Phase 1

Started

2024-03-06

Last updated

2026-06-30

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

SBT777101

SBT777101: Experimental treatment

Study 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. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Body mass index (BMI) \<35 kg/m\^2, inclusive * Adult-onset, moderate-to-severe rheumatoid arthritis (RA) * Moderate-to-severe active disease * b/tsDMARD failure criterion (≥2) * Swollen joint count ≥4 * 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

Primary outcome measure(s)

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

Trial sites (9)

Facility	City	Region	Status
Mayo Clinic	Scottsdale	Arizona	Recruiting
UCSF Medical Center	San Francisco	California	Recruiting
Stanford Medical Center	Stanford	California	Recruiting
University of Colorado	Aurora	Colorado	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
Tufts University	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Oregon Health Sciences University	Portland	Oregon	Recruiting

More Sonoma Biotherapeutics, Inc. trials in the USA

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa Active, not recruiting

A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic Recruiting

Other trials for the same condition

A Study of AZD0120 in Autoimmune Diseases Recruiting

Insignia™ Hip Stem Outcomes Study Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) Active, not recruiting

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors) Recruiting

Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06201416 on ClinicalTrials.gov ↗ ← All trials in the USA