Recruiting
Phase 1

SBT777101

Sponsor:

Sonoma Biotherapeutics, Inc.

Code:

NCT06201416

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

SBT777101

Study Details

Brief 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.

Conditions

Rheumatoid Arthritis

Study ID

NCT06201416

Start date

Mar 6, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - SBT777101 Dose 1

Low dose SBT777101

experimental: Cohort 2 - SBT777101 Dose 2

Mid dose SBT777101

experimental: Cohort 3 - SBT777101 Dose 3

High dose SBT777101

experimental: Cohort 4 - SBT777101 Split-Dose Administration

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.

Interventions

SBT777101

Experimental treatment

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) ]
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Day of treatment to end of DLT evaluation period (28 days) ]

Central Contacts and Locations

Central contacts

Sabrina Fox-Bosetti, MPH

415-992-6245clinicaloperations@sonomabio.com

Jason Do

415-992-6245clinicaloperations@sonomabio.com

Locations

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Megan Hall

401-301-6373hall.megan@mayo.edu

UCSF Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Alex Carvidi

628-206-2505alexcarvidi@ucsf.edu

Stanford Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Uma Vilas Ayachit

925-860-8966

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jennifer Seifert

303-724-7541jennifer.seifert@cuanschutz.edu

Andrew Clauw

303-724-7541andrew.clauw@cuanschutz.edu

Principal Investigator:

Larry Moreland, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

John Seagrist

312-503-0565john.seagrist@northwestern.edu

Tufts University

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Andreas Klein

617-636-5409tmncccr@tuftsmedicine.org

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Daniella Cook

617-726-3914dtcook@mgh.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Oliva Gabriel

617-525-8250ogabriel@bwh.harvard.edu

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Issabell Melz

503-346-9701melz@ohsu.edu

More Information

Sponsor

Sonoma Biotherapeutics, Inc.

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • rheumatoid arthritis
  • safety
  • regulatory T cells
  • CART
  • Treg
  • Inflammatory disease
  • autoimmune disease
  • autologous
  • cell therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sonoma Biotherapeutics, Inc. on 2026-06-30.