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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-71
SponsorSonoma Biotherapeutics, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Participation in the study is not in the subject's best interest, in the opinion of the Investigator

Trial design

Treatments tested in this trial

  • Long Term Safety Monitoring Procedures

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators