RECRUITING

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-03-06
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06201416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) \<35 kg/m\^2, inclusive
  2. * Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
  3. * Moderate-to-severe active disease
  4. * Clinical and/or ultrasound evidence of synovitis
  5. * Prior inadequate response to or unable to tolerate available RA therapies
  6. * Stable doses of RA medications for at least 30 days
  7. * Use of highly effective methods of contraception
  1. * Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
  2. * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
  3. * Recurrent infections or active infection
  4. * Active or untreated latent tuberculosis
  5. * Primary or secondary immunodeficiency
  6. * History of or current inflammatory joint disease other than RA

Contacts and Locations

Study Contact

Sabrina Fox-Bosetti, MPH
CONTACT
415-992-6245
clinicaloperations@sonomabio.com
Ari Bitton
CONTACT
415-992-6245
clinicaloperations@sonomabio.com

Principal Investigator

Joseph Arron, MD
STUDY_DIRECTOR
Sonoma Biotherapeutics, Inc.

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
UCSF Medical Center
San Francisco, California, 94143
United States
Stanford Medical Center
Stanford, California, 94305
United States
University of Colorado
Aurora, Colorado, 80045
United States
Northwestern University
Chicago, Illinois, 60611
United States
Tufts University
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Sonoma Biotherapeutics, Inc.

  • Joseph Arron, MD, STUDY_DIRECTOR, Sonoma Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis