RECRUITING

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

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Conditions

Rheumatoid Arthritis (RA)Hidradenitis Suppurativa (HS)Rheumatoid ArthritisLong Term Follow Up StudyTregSBT0000-01Hidradenitis SuppurativaSBT777101SBT777101-01SBT777101-02

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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

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

Official Title

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

Quick Facts

Study Start:2025-07-22
Study Completion:2040-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07123038

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 71 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.
  2. * Subject understands the purpose and risks of the study and is willing to provide written informed consent.
  3. * Subject is willing to comply with all study procedures for the follow-up period.
  1. * Participation in the study is not in the subject's best interest, in the opinion of the Investigator

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

Dr. Mei-Lun Wang, MD
STUDY_DIRECTOR
Sonoma Biotherapeutics

Study Locations (Sites)

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
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Duke University
Durham, North Carolina, 27708
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Sonoma Biotherapeutics, Inc.

  • Dr. Mei-Lun Wang, MD, STUDY_DIRECTOR, Sonoma Biotherapeutics

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 Date2025-07-22
Study Completion Date2040-12

Study Record Updates

Study Start Date2025-07-22
Study Completion Date2040-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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