MedTrace Logo

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

NCT07123038 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-04-16

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Sonoma Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Baxter, MD, PhD · Sonoma Biotherapeutics

Eligibility

Min Age
18 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2040-12-31
Completion
2040-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123038 on ClinicalTrials.gov