Actively Recruiting

Age: 18Years - 71Years
All Genders
NCT07123038

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

Led by Sonoma Biotherapeutics, Inc. · Updated on 2026-04-16

36

Participants Needed

10

Research Sites

801 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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 Participate

Age: 18Years - 71Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

2

Stanford Medical Center

Stanford, California, United States, 94305

Actively Recruiting

3

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Tufts University

Boston, Massachusetts, United States, 02111

Actively Recruiting

6

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

7

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

8

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Not Yet Recruiting

9

Duke University

Durham, North Carolina, United States, 27708

Not Yet Recruiting

10

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Not Yet Recruiting

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Research Team

S

Sabrina Fox-Bosetti, MPH

CONTACT

J

Jason Do

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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