A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

Part of paid clinical trials in San Francisco, California.

Sponsor
Sonoma Biotherapeutics, Inc.
Study ID
NCT07123038
Status
Recruiting
Apply to this trial

Conditions

  • Hidradenitis Suppurativa (HS)
  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 71 Years
Healthy Volunteers
Not accepted

Interventions

  • Long Term Safety Monitoring Procedures — OTHER
    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.

Study Details

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

Key Dates

Start date
Jul 22, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2040
Completion
Dec 31, 2040

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Participants exposed to SBT777101 Treg cell therapy
    Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)

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

Locations (10)

FacilityCityStateZIPSite coordinators
UCSF Medical CenterSan FranciscoCalifornia94143
Alex Carvidi
[email protected]
628-206-2505
Stanford Medical CenterStanfordCalifornia94305
Uma Vilas Ayachit
925-860-8966
University of ColoradoAuroraColorado80045
Jennifer Seifert
[email protected]
303-724-7541
Northwestern UniversityChicagoIllinois60611
John Seagrist
[email protected]
312-503-0565
Brigham and Women's HospitalBostonMassachusetts02115
James P Sullivan
[email protected]
617-525-8250
Massachusetts General HospitalBostonMassachusetts02114
Daniella Cook
[email protected]
617-726-3914
Tufts UniversityBostonMassachusetts02111
Andreas Klein
[email protected]
617-636-5409
University of MinnesotaMinneapolisMinnesota55455
Irmina Wallander
[email protected]
612-624-5721
Duke UniversityDurhamNorth Carolina27708
Laura Van Althuis
[email protected]
919-668-4312
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Stacie Stutte
[email protected]
713-794-1918

Find similar trials in San Francisco, CA

By research site
UCSF Medical Center· San Francisco, CAStanford Medical Center· Stanford, CAUniversity of Colorado· Aurora, CONorthwestern University· Chicago, ILBrigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

Related Studies