Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sonoma Biotherapeutics, Inc.
Study ID
NCT06201416
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SBT777101 — BIOLOGICAL
    Experimental treatment

Study Details

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.

Key Dates

First listed
Jan 11, 2024
Start date
Mar 6, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Megan Hall
[email protected]
401-301-6373
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
Andrew Clauw
[email protected]
303-724-7541
Larry Moreland, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
John Seagrist
[email protected]
312-503-0565
Brigham and Women's HospitalBostonMassachusetts02115
Oliva Gabriel
[email protected]
617-525-8250
Massachusetts General HospitalBostonMassachusetts02114
Daniella Cook
[email protected]
617-726-3914
Tufts UniversityBostonMassachusetts02111
Andreas Klein
[email protected]
617-636-5409
Oregon Health Sciences UniversityPortlandOregon97239
Issabell Melz
[email protected]
503-346-9701

Find similar trials in Scottsdale, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Mayo Clinic· Scottsdale, AZUCSF Medical Center· San Francisco, CAStanford Medical Center· Stanford, CAUniversity of Colorado· Aurora, CONorthwestern University· Chicago, ILBrigham and Women's Hospital· Boston, MA

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