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Study of SBT777101 for Rheumatoid Arthritis

This study is testing a new treatment called SBT777101 for people with moderate-to-severe rheumatoid arthritis (RA). This is the first time SBT777101 is being given to humans. Researchers want to see how safe it is and what effects it has when given as a single dose. They will start with low doses and increase them if safe. The study may also explore giving the treatment in two doses, about 6 weeks apart. You may be able to join if you are 18-70 years old, have moderate-to-severe RA, and haven't responded well to at least two other RA treatments. The main goal is to check for any side effects and how well you tolerate the treatment. The study status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 48 participants. It will involve giving increasing single doses of SBT777101, and potentially split doses, to evaluate safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability from the day of treatment until the end of the follow-up period, which is 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06201416

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Sonoma Biotherapeutics, Inc.
~48 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:SBT777101

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Measured over Day of treatment to end of follow-up period (48 weeks)
+1 more outcome measured

Conditions

Rheumatoid Arthritis

Explore related trials

Rheumatoid Arthritis

Where it's being run

9 sites across 6 states
Massachusetts3
California2
Arizona1
Colorado1
Illinois1
Oregon1

Study leadership

  • Sarah Baxter, MD, PhD · STUDY_DIRECTOR · Sonoma Biotherapeutics, Inc.

Who to contact

Sabrina Fox-Bosetti, MPH
[email protected]
415-992-6245
Email the study team

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Do you actually qualify for this trial?

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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
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

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

What this trial measures

  • 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