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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 71 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

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

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Daniella Cook
617-726-3914
dtcook@mgh.edu

More Details

Status
Recruiting
Sponsor
Sonoma Biotherapeutics, Inc.

Study Contact

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

Detailed Description

The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.