Non Infectious UveitisPhase 1PEACOCXNCT07427628
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
A Phase 1 study testing TRX103 in people with Non Infectious Uveitis, run by Quan Dong Nguyen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Infectious Uveitis
- What is being tested?
- TRX103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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).
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- 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.
Who cannot join
- 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.
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- 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
- IL-6 inhibitors within 8 weeks
- Therapeutic agents targeted to IL-17 within 4 months
- Agents that modulate B cells within 6 months
- Therapeutic agents targeted to IL-12 or IL-23 within 6 months
- Has received intraocular or periocular (including subtenon, intracanalicular) corticosteroids within 8 weeks prior to TRX103 dose, unless otherwise specified below:
- Retisert® or Yutiq® (glucocorticosteroid implants) within 3 years prior or has had complications related to the implant;
- Retisert® (glucocorticosteroid implant) removed within 3 months prior or has had complications related to device removal;
- Ozurdex® (dexamethasone implant) or Xipere™ (suprachoroidal triamcinolone) within 4 months prior.
- 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.
- Any of the following cardiovascular risk factors:
- History of NYHA Class III or IV criteria cardiac insufficiency
- Clinically significant cardiac dysrhythmia
- QTcF > 450 msec (male) or > 470 msec for (female)
- Unstable angina in last 3 months;
- Myocardial infarction within past year
- CABG surgery past year.
- Impaired kidney function, defined as any of the following:
- 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
- Proteinuria, defined as urine protein/creatinine ratio > 25
- Symptomatic nephrolithiasis within 6 months of screening.
- 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.
- Anaphylaxis to fluorescein or unwillingness to undergo fluorescein angiograms.
- Live vaccine within 6 weeks prior to Day 0 (day of infusion) or expected to need a live vaccine during the study.
- Active bacterial, viral, fungal, mycobacterial, or other infections that would require treatment. Active infections must be resolved prior to enrollment.
- Have required management of infections as follows:
- Currently on suppressive therapy for any chronic infection
- Hospitalization for infection within past 60 days
- Use of IV or IM antibacterials, antivirals, antifungals, or anti- parasitic agents within past 60 days
- History of disseminated herpes zoster, history of or invasive HSV, or recurrent (≥ 2 episodes within last 5 years) localized herpes zoster
- Infection with Mycobacterium tuberculosis (TB).
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
- Positive serology for HIV.
- Lab test results indicating active syphilis infection.
- History of significant trauma or major surgery within 4 weeks prior to TRX103 dose or scheduled to undergo major surgery during the study.
- History of blood transfusion within the last 3 years.
- Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant.
- 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.
- Screening laboratory and other analyses show any of the following abnormal results:
- Serum aspartate transaminase or alanine transaminase > 3.0 × upper limit of normal;
- Bilirubin ≥ 2 x ULN;
- Total white blood cell count < 2,000/μL;
- Hemoglobin < 8 g/dL;
- Platelet count < 100,000/μL;
- Absolute neutrophil count < 1,200/μL;
- Absolute lymphocytes count < 750/μL.
- Subjects with a history of any other significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support such dysfunction.
- 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:
- Places the subject at increased risk during participation in the study, and/or;
- 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.
- Participation in any other clinical trial/ or receiving any other investigational treatment while enrolled in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Eye Institute
Palo Alto, California, 94303
Byers Eye Institute, 650-724-8553, ngocthan@stanford.edu
Cristian De Los Santos, nguyenlabtrials@stanford.edu
About this study
Official title: 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.
- Conditions
- Non Infectious Uveitis
- Being tested
- TRX103
- Keywords
- Uveitis, NIU, Cell Therapy, Treg, TRX103
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX103Biological
TRX103 infusion via peripheral line
| Study group | Role | What they receive |
|---|---|---|
| TRX-103 Inpatient | Experimental | Infusion of TRX103 followed by 8 hour in patient observation period Receives: Biological: TRX103 |
| TRX-103 Outpatient | Experimental | Outpatient Infusion of TRX103 followed by outpatient observation period Receives: Biological: TRX103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to a year
Incidence of infections, either bacterial, fungal or viral at week 52
Measured: 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
Measured: At 3-month, 6-month, and 1-year.
Secondary outcomes (3)
Change in Best-Corrected Visual acuity (BCVA) at week 52, compared to Baseline
Measured: Up to a year
Change in Central subfield thickness on OCT at week 52 from baseline
Measured: Upto a year
Change in quality of life at week 52 using NEI VFQ 25 compared to Baseline
Measured: Upto a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start18 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Infectious UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quan Dong Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Dong Nguyen, Stanford University
- Investigators
- Quan Nguyen, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427628
- Sponsor's protocol ID
- 83815
- Acronym
- PEACOCX
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07427628
- Acronym / sponsor ID
- PEACOCX / 83815
- Conditions
- Non Infectious Uveitis
- Keywords
- Uveitis, NIU, Cell Therapy, Treg, TRX103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Quan Dong NguyenUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRX-103 Inpatient | Experimental | Biological: TRX103Infusion of TRX103 followed by 8 hour in patient observation period |
| TRX-103 Outpatient | Experimental | Biological: TRX103Outpatient Infusion of TRX103 followed by outpatient observation period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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:
- Subjects on treatment with corticosteroids may be included if they meet the following:
Key exclusion criteria (66 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX103TRX103 infusion via peripheral line | Biological | TRX-103 Inpatient, TRX-103 Outpatient |
Primary outcome
Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52
Time frame: Up to a year
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
Time frame: Upto 1 year
Negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.
Time frame: At 3-month, 6-month, and 1-year.
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
3 secondary outcomes
Change in Best-Corrected Visual acuity (BCVA) at week 52, compared to Baseline
Time frame: Up to a year
Change in Central subfield thickness on OCT at week 52 from baseline
Time frame: Upto a year
Change in quality of life at week 52 using NEI VFQ 25 compared to Baseline
Time frame: Upto a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quan Nguyen, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRX103 in people with Non Infectious Uveitis, run by Quan Dong Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 66 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PEACOCX Study Team (650-497-2078, nguyenlabtrials@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52 (time frame: Up to a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.