A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis

NCT07427628 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TRX103-PEACOCX
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Infectious Uveitis

Keywords

Uveitis; NIU; Cell Therapy; Treg; TRX103

Outcome Measures

Primary Outcomes (3)

• 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

  Up to a year

• Incidence of infections, either bacterial, fungal or viral at week 52

  Upto 1 year

• 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

  At 3-month, 6-month, and 1-year.

Secondary Outcomes (3)

• Change in Best-Corrected Visual acuity (BCVA) at week 52, compared to Baseline

  Up to a year

• Change in Central subfield thickness on OCT at week 52 from baseline

  Upto a year

• Change in quality of life at week 52 using NEI VFQ 25 compared to Baseline

  Upto a year

Study Arms (2)

TRX-103 Inpatient

EXPERIMENTAL

Infusion of TRX103 followed by 8 hour in patient observation period

Biological: TRX103

TRX-103 Outpatient

EXPERIMENTAL

Outpatient Infusion of TRX103 followed by outpatient observation period

Biological: TRX103

Interventions

TRX103 BIOLOGICAL

TRX103 infusion via peripheral line

TRX-103 Inpatient; TRX-103 Outpatient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• Have been on a stable dose for at least 7 days prior to TRX103 dose.
• No ongoing treatment with a systemic non-corticosteroid, biologic, small molecules or immunomodulatory agent.
• If the patient is on specific therapies such as systemic non-corticosteroid biologic agents, immunomodulatory agents or small molecules etc., appropriate washout periods defined in the protocol must be met prior to infusion at Day 0.

You may not qualify if:

• 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.
• Macular edema as the only sign of uveitis, defined on OCT without active anterior/posterior inflammatory signs.
• Age-related macular degeneration or serpiginous choroidopathy.
• Myopic degeneration with active sub-foveal choroidal neovascularization.
• Confirmed or suspected current infectious uveitis.
• Has ocular masquerade syndrome, like ocular lymphoma.
• Any of the following ongoing treatments or anticipated use of any of the following treatments prior to TRX103 dose, for the time periods specified below:
• Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
• Small molecules, e.g., JAK inhibitors or TYK2 inhibitors within 4 weeks
• Anti-vascular endothelial growth factor (anti-VEGF) therapy within 8 weeks
• TNF inhibitor therapy within 8 weeks
• Agents that modulate T cells within 3 months

Sponsors & Collaborators

• Quan Dong Nguyen: lead

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Quan Nguyen, MD

  Stanford University

  STUDY CHAIR

Central Study Contacts

PEACOCX Study Team

CONTACT

650-497-2078; nguyenlabtrials@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)