Rheumatoid ArthritisPhase 1Regulate-RANCT06201416
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing SBT777101 in people with Rheumatoid Arthritis, run by Sonoma Biotherapeutics, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SBT777101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Mar 2024to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Jennifer Seifert, 303-724-7541, jennifer.seifert@cuanschutz.edu
Andrew Clauw, 303-724-7541, andrew.clauw@cuanschutz.edu
- Recruiting
Tufts University
Boston, Massachusetts, 02111
Andreas Klein, 617-636-5409, tmncccr@tuftsmedicine.org
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Daniella Cook, 617-726-3914, dtcook@mgh.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Oliva Gabriel, 617-525-8250, ogabriel@bwh.harvard.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
John Seagrist, 312-503-0565, john.seagrist@northwestern.edu
- Recruiting
Oregon Health Sciences University
Portland, Oregon, 97239
Issabell Melz, 503-346-9701, melz@ohsu.edu
- Recruiting
UCSF Medical Center
San Francisco, California, 94143
Alex Carvidi, 628-206-2505, alexcarvidi@ucsf.edu
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Megan Hall, 401-301-6373, hall.megan@mayo.edu
- Recruiting
Stanford Medical Center
Stanford, California, 94305
Uma Vilas Ayachit, 925-860-8966
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
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.
Read the 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 (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SBT777101
- Keywords
- rheumatoid arthritis, safety, regulatory T cells, CART, Treg, Inflammatory disease, autoimmune disease, autologous, cell therapy
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBT777101Biological
Experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - SBT777101 Dose 1 | Experimental | Low dose SBT777101 Receives: Biological: SBT777101 |
| Cohort 2 - SBT777101 Dose 2 | Experimental | Mid dose SBT777101 Receives: Biological: SBT777101 |
| Cohort 3 - SBT777101 Dose 3 | Experimental | High dose SBT777101 Receives: Biological: SBT777101 |
| Cohort 4 - SBT777101 Split-Dose Administration | Experimental | Participants receive two intravenous infusions of SBT777101 derived from a single manufacturing process. Total administered dose ranges from approximately 300 million to 900 million CAR+ Treg cells, divided across two administrations. Receives: Biological: SBT777101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Measured: Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of dose-limiting toxicities (DLTs)
Death, CRS, ICANS, vital organ toxicity, hematological toxicity
Measured: Day of treatment to end of DLT evaluation period (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start6 Mar 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single Ascending Dose Cohorts (Cohorts 1-3) Split-Dose Cohort (Cohort 4)
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Baxter, MD, PhD, Study director, Sonoma Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201416
- Sponsor's protocol ID
- SBT777101-01
- Acronym
- Regulate-RA
- Status last verified
- Jun 2026
- First submitted
- 1 Jan 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06201416
- Acronym / sponsor ID
- Regulate-RA / SBT777101-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, safety, regulatory T cells, CART, Treg, Inflammatory disease, autoimmune disease, autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sonoma Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single Ascending Dose Cohorts (Cohorts 1-3) Split-Dose Cohort (Cohort 4)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - SBT777101 Dose 1 | Experimental | Biological: SBT777101Low dose SBT777101 |
| Cohort 2 - SBT777101 Dose 2 | Experimental | Biological: SBT777101Mid dose SBT777101 |
| Cohort 3 - SBT777101 Dose 3 | Experimental | Biological: SBT777101High dose SBT777101 |
| Cohort 4 - SBT777101 Split-Dose Administration | Experimental | Biological: SBT777101Participants receive two intravenous infusions of SBT777101 derived from a single manufacturing process. Total administered dose ranges from approximately 300 million to 900 million CAR+ Treg cells, divided across two administrations. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBT777101Experimental treatment | Biological | Cohort 1 - SBT777101 Dose 1, Cohort 2 - SBT777101 Dose 2, Cohort 3 - SBT777101 Dose 3, Cohort 4 - SBT777101 Split-Dose Administration |
Primary outcome
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Time frame: Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Day of treatment to end of DLT evaluation period (28 days)
Death, CRS, ICANS, vital organ toxicity, hematological toxicity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Baxter, MD, PhD study director
Sonoma Biotherapeutics, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBT777101 in people with Rheumatoid Arthritis, run by Sonoma Biotherapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Fox-Bosetti, MPH (415-992-6245, clinicaloperations@sonomabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of adverse events [Safety and Tolerability] (time frame: Day of treatment to end of follow-up period (48 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.