← Back to Search

Monoclonal Antibodies

SBT777101 for Rheumatoid Arthritis (Regulate-RA Trial)

Phase 1
Recruiting
Research Sponsored by Sonoma Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe active disease
Prior inadequate response to or unable to tolerate available RA therapies
Must not have
Recurrent infections or active infection
Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of treatment to end of dlt evaluation period (28 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called SBT777101 for people with rheumatoid arthritis. The study will look at whether it is safe and how it affects the participants. The treatment will be

Who is the study for?
This trial is for adults with moderate-to-severe rheumatoid arthritis who haven't responded well to existing treatments. Participants must have a BMI under 35, at least one joint suitable for biopsy, and evidence of inflammation. They should be on stable RA medication doses for 30 days and use effective contraception. Excluded are those with recent major surgery, uncontrolled diseases in various organs, frequent infections or active tuberculosis, and other inflammatory joint diseases.
What is being tested?
The study tests SBT777101's safety and effects as a single dose in humans with rheumatoid arthritis. It starts at low doses which increase once earlier levels are proven safe. This is the first time this treatment is being tested in people.
What are the potential side effects?
Since this is the first human trial of SBT777101, specific side effects aren't listed yet but may include typical drug reactions such as injection site discomfort, allergic reactions, or symptoms related to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is currently moderate to severe.
Select...
I have not responded well to or couldn't tolerate existing RA treatments.
Select...
I have moderate-to-severe rheumatoid arthritis that started in adulthood.
Select...
I have a joint suitable for a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I frequently get infections or currently have an infection.
Select...
I do not have uncontrolled heart, lung, kidney, liver, hormone, or stomach/intestine diseases.
Select...
I have or had an inflammatory joint disease that is not rheumatoid arthritis.
Select...
I have a condition that weakens my immune system.
Select...
I have active or untreated latent tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of treatment to end of dlt evaluation period (28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of treatment to end of dlt evaluation period (28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and nature of dose-limiting toxicities (DLTs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: SBT777101 Dose 3Experimental Treatment1 Intervention
High dose SBT777101
Group II: SBT777101 Dose 2Experimental Treatment1 Intervention
Mid dose SBT777101
Group III: SBT777101 Dose 1Experimental Treatment1 Intervention
Low dose SBT777101

Find a Location

Who is running the clinical trial?

Sonoma Biotherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
64 Total Patients Enrolled
Joseph Arron, MDStudy DirectorSonoma Biotherapeutics, Inc.
Mark Eisner, MDStudy DirectorSonoma Biotherapeutics, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled
~16 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top