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 range18 Years – 70 Years
SexALL
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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:
✓. Prednisone ≤ 20 mg/day; or an equivalent dose of another corticosteroid
Exclusion criteria
✕. Any condition preventing evaluation/assessment of both eyes.
✕. Any significant ocular disease that could compromise vision.
✕. Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to non-uveitis causes.
✕. Isolated anterior uveitis.
✕
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.