Purpose of this Study
Observational study.
Who Can Participate?
Eligibility
Must have completed the parent study.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is a Phase 4 observational study. It takes place at several medical centers. The goal is to check the long-term safety of people who have already received a special treatment made by Sonoma Biotherapeutics. This treatment uses gene-modified Treg cells. The study watches how these people do over time after receiving the treatment in an earlier study.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Principal Investigator
Tarannum
Jaleel
Protocol Number
PRO00119094
Phase
IV
Enrollment Status
Pending Open to Enrollment