RECRUITING

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

Description

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

Study Overview

Study Details

Study overview

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

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

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

Condition
Rheumatoid Arthritis (RA)
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Stanford

Stanford Medical Center, Stanford, California, United States, 94305

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Boston

Tufts University, Boston, Massachusetts, United States, 02111

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Durham

Duke University, Durham, North Carolina, United States, 27708

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Participation in the study is not in the subject's best interest, in the opinion of the Investigator

Ages Eligible for Study

18 Years to 71 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sonoma Biotherapeutics, Inc.,

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

Study Record Dates

2040-12