Recruiting

Treg Therapeutic

Sponsor:

Sonoma Biotherapeutics, Inc.

Code:

NCT07123038

Conditions

Rheumatoid Arthritis (RA)

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Long Term Safety Monitoring Procedures

Study Details

Brief summary:

To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Conditions

Rheumatoid Arthritis (RA)

Hidradenitis Suppurativa (HS)

Study ID

NCT07123038

Start date

Jul 22, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.
  • Subject understands the purpose and risks of the study and is willing to provide written informed consent.
  • Subject is willing to comply with all study procedures for the follow-up period.

Exclusion Criteria:

  • Participation in the study is not in the subject's best interest, in the opinion of the Investigator

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants exposed to SBT777101 Treg cell therapy

Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)

Interventions

Long Term Safety Monitoring Procedures

In accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy.

Primary outcome measure

  • Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

Sabrina Fox-Bosetti, MPH

415-992-6245clinicaloperations@sonomabio.com

Jason Do

415-992-6245clinicaloperations@sonomabio.com

Locations

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

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

James P Sullivan

617-525-8250jsullivan126@bwh.harvard.edu

More Information

Sponsor

Sonoma Biotherapeutics, Inc.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Rheumatoid Arthritis
  • Long Term Follow Up Study
  • Treg
  • SBT0000-01
  • Hidradenitis Suppurativa
  • SBT777101
  • SBT777101-01
  • SBT777101-02

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 2026-04-16.