SBT777101 for Rheumatoid Arthritis

(Regulate-RA Trial)

Recruiting at 7 trial locations

Overseen By Sabrina Fox-Bosetti, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sonoma Biotherapeutics, Inc.

Must be taking: RA medications

Disqualifiers: Uncontrolled disease, Infections, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SBT777101 for individuals with rheumatoid arthritis, a condition that causes painful joint swelling. The main goal is to assess the safety of SBT777101 and its effects at different dose levels. Participants will help researchers learn how the body processes this new treatment. Those with moderate-to-severe rheumatoid arthritis, who have not responded well to current treatments, and have stable medication doses might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their rheumatoid arthritis medications for at least 30 days before joining, so you won't need to stop taking your current medications.

Is there any evidence suggesting that SBT777101 is likely to be safe for humans?

Research has shown that SBT777101 has a good safety record in early studies. This treatment is being tested for rheumatoid arthritis, and initial results suggest that patients tolerate it well. So far, studies have not reported any serious side effects, indicating that most patients did not experience harmful reactions. This marks the first time the treatment has been tested in humans, focusing on safety and tolerability. Researchers are trying different doses to ensure its safe use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SBT777101 for rheumatoid arthritis because it might work differently from current treatments like methotrexate and biologics. Unlike these standard options, which generally suppress the immune system broadly, SBT777101 potentially targets specific pathways involved in inflammation. This targeted approach could mean fewer side effects and a more effective treatment for patients. Moreover, with different dosing options being explored, SBT777101 offers flexibility in finding the most effective and tolerable dose for individuals.

What evidence suggests that SBT777101 might be an effective treatment for rheumatoid arthritis?

Research has shown that SBT777101 could help treat rheumatoid arthritis. Early trials found it safe and showed initial signs of effectiveness in patients who haven't responded to other treatments. SBT777101 operates differently from many other treatments by using special cells to potentially reduce harmful inflammation. Initial studies suggest it might help manage symptoms in patients with challenging cases of rheumatoid arthritis. Although this is an early study, the first results are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph Arron, MD

Principal Investigator

Sonoma Biotherapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition is currently moderate to severe.

I have not responded well to or couldn't tolerate existing RA treatments.

Body mass index (BMI) <35 kg/m^2, inclusive

Exclusion Criteria

I do not have uncontrolled heart, lung, kidney, liver, hormone, or stomach/intestine diseases.

I frequently get infections or currently have an infection.

I have or had an inflammatory joint disease that is not rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of SBT777101 to evaluate safety and effects

1 day

DLT Evaluation

Participants are monitored for dose-limiting toxicities and other adverse effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SBT777101

Trial Overview 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.

How Is the Trial Designed?

Group I: SBT777101 Dose 3 Experimental Treatment 1 Intervention

High dose SBT777101

Group II: SBT777101 Dose 2 Experimental Treatment 1 Intervention

Mid dose SBT777101

Group III: SBT777101 Dose 1 Experimental Treatment 1 Intervention

Low dose SBT777101

Who Is Running the Clinical Trial?

Sonoma Biotherapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

Rheumatoid arthritis (RA) treatment options have expanded significantly with the introduction of various biological agents, including TNF antagonists and other targeted therapies, which have shown efficacy in clinical trials.

Recent studies have explored new therapeutic targets, such as IL-6 and intracellular kinases, indicating ongoing advancements in RA treatment and the importance of understanding their mechanisms for safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapeutics for rheumatoid arthritis. Bingham, CO.[2008]

Patients with rheumatoid arthritis (RA) who experience high disease activity at diagnosis or have a prolonged time from diagnosis to treatment are at greater risk of developing 'difficult-to-treat' (D2T) RA, highlighting the importance of early intervention.

Current literature indicates that while some clinical factors like obesity and psychological conditions may influence D2T RA, more research is needed to better define and manage this condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Difficult-to-Treat Rheumatoid Arthritis: Definition, Clinical Presentation, and Management. Conran, C., Kolfenbach, J., Kuhn, K., et al.[2023]

Anti-TNF biologics have significantly changed the treatment landscape for rheumatoid arthritis, but many patients still experience inadequate disease control, highlighting the need for personalized treatment approaches.

A variety of new biologic disease-modifying anti-rheumatic drugs are becoming available, which may help tailor therapies to individual patients and improve overall management of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-tumor necrosis factor-based biologic therapies for rheumatoid arthritis: present, future, and insights into pathogenesis. Paula, FS., Alves, JD.[2021]

The introduction of TNF-α inhibitors has revolutionized the treatment of rheumatoid arthritis (RA), leading to the development of numerous new biologic agents that target different aspects of the immune system.

This review highlights both approved immune modulators and those in development, detailing their mechanisms of action and providing updates on their efficacy and safety, indicating a wide range of effective treatment options for RA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune modulation of rheumatoid arthritis. Pappas, DA., Geraldino-Pardilla, L., Bathon, JM.[2022]

Biological therapies for rheumatoid arthritis show significant variability in effectiveness and side effects among patients, highlighting the need for personalized medicine to tailor treatments to individual responses.

Current research aims to identify predictors of treatment response and adverse effects, which could lead to better matching of patients with therapies and potentially lower treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for personalised medicine for rheumatoid arthritis. Isaacs, JD., Ferraccioli, G.[2015]

Citations

1. sonomabio.com sonomabio.com/2025/10/sonoma-biotherapeutics-announces-positive-interim-safety-and-efficacy-data-from-phase-1-regulate-ra-study-of-sbt-77-7101-in-refractory-rheumatoid-arthritis/

Sonoma Biotherapeutics Favorable early safety profile with preliminary clinical and mechanistic evidence of therapeutic activity in refractory rheumatoid arthritis.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725014645

A Phase 1 Study of CAR-T Regulatory Cells Targeting ... In contrast to most existing CAR-T immunotherapies, which harness effector T cells to kill pathogenic target cells, the goal of treatment with SBT777101 is to ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06201416

Study of Single Doses of SBT777101 in Subjects With ... This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis.

4. mayo.edu mayo.edu/research/clinical-trials/cls-20562516

Study of Single Doses of SBT777101 in Subjects With ... The purpose of this study is to evaluate and characterize the safety and tolerability of SBT777101, inclusing incidence, nature, and severity of adverse events.

5. pharmatimes.com pharmatimes.com/news/sonoma-biotherapeutics-reports-promising-early-data-from-phase-1-rheumatoid-arthritis-trial/

Sonoma Biotherapeutics reports promising early data from ... SBT-77-7101 shows favourable safety and early signs of efficacy in patients with refractory RA.

6. acrabstracts.org acrabstracts.org/abstract/a-phase-1-study-of-autologous-car-treg-cells-in-refractory-rheumatoid-arthritis-interim-report-of-safety-and-efficacy/

A Phase 1 Study of Autologous CAR-Treg Cells in ... Regulate-RA is an ongoing first-in-human, phase 1 study evaluating the safety and tolerability of SBT777101 in patients with refractory RA.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/rheumatoid-arthritis

UCSF Rheumatoid Arthritis Clinical Trials for 2025 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 ...