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.
≥ 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.
.≥ 2+ VH (NEI/SUN Scale) OR
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.
Sequential
TRX103
Biological/VaccineTRX103 infusion via peripheral line
Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52
Detailed physical and eye exams, labs and imaging to be performed at study visits for documenting safety and AE's graded using CTCAE V6.0
Incidence of infections, either bacterial, fungal or viral at week 52
Negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.
Participants will be tested via pre-defined blood draw for Replication Competent Lentivirus as per FDA guidance for Testing of Retroviral Vector-Based Human Gene Therapy Products
Change in Best-Corrected Visual acuity (BCVA) at week 52, compared to Baseline
Change in Central subfield thickness on OCT at week 52 from baseline
Change in quality of life at week 52 using NEI VFQ 25 compared to Baseline
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Quan Dong Nguyen
Lead sponsor
Stanford University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
