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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Infectious Uveitis
• Intervention / Treatment: Biological: TRX103

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: PEACOCX Study Team; Phone Number: 650-497-2078; Email: nguyenlabtrials@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute
      • Contact: Byers Eye Institute; Phone Number: 650-724-8553; Email: nyavari@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 tomography (OCT).

5. Subjects on treatment with corticosteroids may be included if they meet the following:

   1. Prednisone ≤ 20 mg/day; or an equivalent dose of another corticosteroid
   2. Have been on a stable dose for at least 7 days prior to TRX103 dose.
   3. No ongoing treatment with a systemic non-corticosteroid, biologic, small molecules or immunomodulatory agent.
6. 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.

Exclusion Criteria:

1. Any condition preventing evaluation/assessment of both eyes.
2. Any significant ocular disease that could compromise vision.
3. Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to non-uveitis causes.
4. Isolated anterior uveitis.
5. Macular edema as the only sign of uveitis, defined on OCT without active anterior/posterior inflammatory signs.
6. Age-related macular degeneration or serpiginous choroidopathy.
7. Myopic degeneration with active sub-foveal choroidal neovascularization.
8. Confirmed or suspected current infectious uveitis.
9. Has ocular masquerade syndrome, like ocular lymphoma.

10. 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:

    1. Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
    2. Small molecules, e.g., JAK inhibitors or TYK2 inhibitors within 4 weeks
    3. Anti-vascular endothelial growth factor (anti-VEGF) therapy within 8 weeks
    4. TNF inhibitor therapy within 8 weeks
    5. Agents that modulate T cells within 3 months
    6. IL-6 inhibitors within 8 weeks
    7. Therapeutic agents targeted to IL-17 within 4 months
    8. Agents that modulate B cells within 6 months
    9. Therapeutic agents targeted to IL-12 or IL-23 within 6 months

11. Has received intraocular or periocular (including subtenon, intracanalicular) corticosteroids within 8 weeks prior to TRX103 dose, unless otherwise specified below:

    1. Retisert® or Yutiq® (glucocorticosteroid implants) within 3 years prior or has had complications related to the implant;
    2. Retisert® (glucocorticosteroid implant) removed within 3 months prior or has had complications related to device removal;
    3. Ozurdex® (dexamethasone implant) or Xipere™ (suprachoroidal triamcinolone) within 4 months prior.
12. Ocular surgery within 90 days prior to TRX103 dose in the study eye, including glaucoma surgery (trabeculectomy or aqueous shunt device), and vitreoretinal surgery. Nd: YAG capsulotomy within 30 days prior to TRX103 dose in the study eye is also an exclusion criterion.

13. Any of the following cardiovascular risk factors:

    1. History of NYHA Class III or IV criteria cardiac insufficiency
    2. Clinically significant cardiac dysrhythmia
    3. QTcF > 450 msec (male) or > 470 msec for (female)
    4. Unstable angina in last 3 months;
    5. Myocardial infarction within past year
    6. CABG surgery past year.

14. Impaired kidney function, defined as any of the following:

    1. Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or as measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation < 40 mL/min/1.73 m2
    2. Proteinuria, defined as urine protein/creatinine ratio > 25
    3. Symptomatic nephrolithiasis within 6 months of screening.
15. Subjects who are breastfeeding, pregnant, or planning to become pregnant, or subjects of childbearing potential who are unwilling to apply a highly effective birth control method prior to TRX103 dose.
16. Anaphylaxis to fluorescein or unwillingness to undergo fluorescein angiograms.
17. Live vaccine within 6 weeks prior to Day 0 (day of infusion) or expected to need a live vaccine during the study.
18. Active bacterial, viral, fungal, mycobacterial, or other infections that would require treatment. Active infections must be resolved prior to enrollment.

19. Have required management of infections as follows:

    1. Currently on suppressive therapy for any chronic infection
    2. Hospitalization for infection within past 60 days
    3. Use of IV or IM antibacterials, antivirals, antifungals, or anti- parasitic agents within past 60 days
    4. History of disseminated herpes zoster, history of or invasive HSV, or recurrent (≥ 2 episodes within last 5 years) localized herpes zoster
    5. Infection with Mycobacterium tuberculosis (TB).
    6. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
    7. Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
    8. Positive serology for HIV.
    9. Lab test results indicating active syphilis infection.
20. History of significant trauma or major surgery within 4 weeks prior to TRX103 dose or scheduled to undergo major surgery during the study.
21. History of blood transfusion within the last 3 years.
22. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant.
23. Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and/or have not recovered from treatment related toxicities.

24. Screening laboratory and other analyses show any of the following abnormal results:

    1. Serum aspartate transaminase or alanine transaminase > 3.0 × upper limit of normal;
    2. Bilirubin ≥ 2 x ULN;
    3. Total white blood cell count < 2,000/μL;
    4. Hemoglobin < 8 g/dL;
    5. Platelet count < 100,000/μL;
    6. Absolute neutrophil count < 1,200/μL;
    7. Absolute lymphocytes count < 750/μL.
25. Subjects with a history of any other significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support such dysfunction.

26. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:

    1. Places the subject at increased risk during participation in the study, and/or;
    2. Interferes with the subject's capacity to provide informed consent and their participation in the study, and/or; interferes with the interpretation of the results.
27. Participation in any other clinical trial/ or receiving any other investigational treatment while enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRX-103 Inpatient; Infusion of TRX103 followed by 8 hour in patient observation period	Biological: TRX103; TRX103 infusion via peripheral line
Experimental: TRX-103 Outpatient; Outpatient Infusion of TRX103 followed by outpatient observation period	Biological: TRX103; TRX103 infusion via peripheral line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Quan Dong Nguyen
• Investigators: Study Chair: Quan Nguyen, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cell Therapy; Uveitis; Treg; NIU; TRX103
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: TRX103-PEACOCX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No