A Proof-of-Concept Trial to EvaluAte the EfficaCy and Safety Of Cell Therapy TRX103 Administered Intravenously in Patients With Active, Non-infectious Intermediate, Posterior, and Pan-Uveitis - PEACOCX Study
Quan Dong Nguyen
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 18 to ≤ 70 years of age at time of consent. 2. Weight of ≥ 40 kg at time of consent. 3. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits. 4. Diagnosis of active non-infectious uveitis (NIU); intermediate, posterior, or panuveitis at screening as defined as having at least ONE of the following findings: 1. .≥ 2+ VH (NEI/SUN Scale) OR 2. Active inflammatory chorioretinal or inflammatory retinal lesion or lesions as defined by fluorescein angiography (FA) or optical coherence tomo…
Interventions
- BiologicalTRX103
TRX103 infusion via peripheral line
Location
- Byers Eye InstitutePalo Alto, California