NCT07123038 A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
| NCT ID | NCT07123038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sonoma Biotherapeutics, Inc. |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2040-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-07-22 with a primary completion date of 2040-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
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
Contact & Investigator
Sarah Baxter, MD, PhD
STUDY DIRECTOR
Sonoma Biotherapeutics
Frequently Asked Questions
Who can join the NCT07123038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 71 Years, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07123038 currently recruiting?
Yes, NCT07123038 is actively recruiting participants. Contact the research team at clinicaloperations@sonomabio.com for enrollment information.
Where is the NCT07123038 trial being conducted?
This trial is being conducted at San Francisco, United States, Stanford, United States, Aurora, United States, Chicago, United States and 6 additional locations.
Who is sponsoring the NCT07123038 clinical trial?
NCT07123038 is sponsored by Sonoma Biotherapeutics, Inc.. The principal investigator is Sarah Baxter, MD, PhD at Sonoma Biotherapeutics. The trial plans to enroll 36 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.