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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 71 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 15 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people who already received a Sonoma Biotherapeutics treatment made from gene-changed regulatory T cells, which help control the immune system. It checks for health problems that appear later, how serious they are, and whether the treatment may have caused them.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You received at least 1 dose of a Sonoma Biotherapeutics gene-changed regulatory T cell treatment in an earlier treatment study.
  • You understand the study's purpose and risks and are willing to sign a form agreeing to take part.
  • You are willing to follow all study steps during the follow-up period.

Who can't join

  • The study doctor thinks taking part is not in your best interest.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (10)

CA

CO

IL

MA

MN

NC

TX