A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients W… (NCT07427628) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
United States18 participantsStarted 2026-03
Plain-language summary
The purpose of this Phase 1, first in uveitis open-label study is to assess the safety and tolerability of TRX-103 in patients with non infectious uveitis (NIU). It is anticipated that up to 18 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 to ≤ 70 years of age at time of consent.
. Weight of ≥ 40 kg at time of consent.
. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
. Diagnosis of active non-infectious uveitis (NIU); intermediate, posterior, or panuveitis at screening as defined as having at least ONE of the following findings:
. .≥ 2+ VH (NEI/SUN Scale) OR
. Active inflammatory chorioretinal or inflammatory retinal lesion or lesions as defined by fluorescein angiography (FA) or optical coherence tomography (OCT).
. Subjects on treatment with corticosteroids may be included if they meet the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial for TRX103, the main goal is to test safety rather than confirm that it works — does that change how you'd weigh this option against my current or standard treatment plan for non-infectious uveitis?
2The trial is monitoring for bacterial, fungal, and viral infections over 52 weeks as a primary safety concern — given my overall health and immune status, do you think I'd be at higher-than-average risk for those kinds of infections with a cell therapy like this?
3The study is checking for something called Replication Competent Lentivirus at 3, 6, and 12 months — can you explain what that means in plain terms and what the consequences would be if that test came back positive?
4This trial hasn't started recruiting yet — if I'm interested, how long might I realistically wait before it opens, and is there a standard treatment I should be on in the meantime to manage my uveitis?
5Cell therapy is a very different approach from typical uveitis treatments — based on what you know about TRX103 and my specific type of non-infectious uveitis, do you think I'd even be a candidate worth discussing with the trial team once it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52
Timeframe: Up to a year
2
Incidence of infections, either bacterial, fungal or viral at week 52
Timeframe: Upto 1 year
3
Negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.