Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07123038

RecruitingN/A

Sponsor: Sonoma Biotherapeutics, Inc.

Conditions: Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS)

Interventions: Long Term Safety Monitoring Procedures

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 71 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (10)
  • San Francisco, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Durham, North Carolina, United States
  • Houston, Texas, United States