TRX103 for Uveitis

(PEACOCX Trial)

PS
Overseen ByPEACOCX Study Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called TRX-103 for individuals with non-infectious uveitis, an inflammatory eye condition. Participants will receive a one-time infusion of TRX-103 and will be monitored for any side effects. The trial seeks individuals with active non-infectious uveitis who may be using corticosteroids, a type of anti-inflammatory medication, but not other specific treatments. As a Phase 1 trial, this research focuses on understanding how TRX-103 functions in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

If you are taking corticosteroids, you can continue as long as the dose is stable and within the specified limit. However, if you are on other specific therapies like biologics or immunomodulatory agents, you will need to stop them and follow a washout period before starting the trial.

Is there any evidence suggesting that TRX103 is likely to be safe for humans?

In earlier studies, TRX103 has shown promising safety results. Research indicates that patients generally tolerated TRX103 well, experiencing only a few side effects. The treatment helped the immune system recover quickly and increased the number of important immune cells. These findings suggest that TRX103 might be safe for people with non-infectious uveitis. However, it's important to remember that this is a Phase 1 trial, marking the first time TRX103 is tested for this condition. More research is needed to fully understand its safety.12345

Why do researchers think this study treatment might be promising for uveitis?

Most treatments for uveitis, like corticosteroids and immunosuppressive drugs, focus on reducing inflammation and suppressing the immune system. However, TRX103 is unique because it targets a different mechanism: it aims to modulate specific inflammatory pathways without broadly suppressing the immune system. Researchers are excited about TRX103 because it could offer a more precise treatment, potentially reducing side effects associated with current therapies. Additionally, TRX103 offers flexibility in administration, with both inpatient and outpatient options, which could improve convenience and accessibility for patients.

What evidence suggests that TRX103 might be an effective treatment for uveitis?

Research has shown that TRX103 is designed to help manage the immune system, which is crucial for conditions like non-infectious uveitis. Early data suggest that TRX103 can calm the immune system, preventing overreactions. In some studies, this has led to longer periods without flare-ups and a reduced need for corticosteroids, which lower inflammation, for many patients. Although more research is needed, the early findings offer promise for those dealing with uveitis. Participants in this trial will receive TRX103 as either an inpatient or outpatient infusion, followed by an observation period.12367

Who Is on the Research Team?

QN

Quan Nguyen, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18–70 with active, non-infectious uveitis who weigh at least 40 kg. Participants must have stable medication use, not be on certain immune-modifying drugs, and meet specific eye inflammation criteria. They need to understand the study and agree to all procedures.

Inclusion Criteria

I am between 18 and 70 years old.
I weigh at least 40 kilograms.
2. Have been on a stable dose for at least 7 days prior to TRX103 dose.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time infusion of TRX-103 followed by observation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Multiple visits at 3-month, 6-month, and 1-year

What Are the Treatments Tested in This Trial?

Interventions

  • TRX103

Trial Overview

The study is testing a single infusion of TRX103 cell therapy in up to 18 people with non-infectious uveitis. The main goal is to see if this new treatment is safe and well-tolerated.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: TRX-103 OutpatientExperimental Treatment1 Intervention
Group II: TRX-103 InpatientExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Quan Dong Nguyen

Lead Sponsor

Trials
3
Recruited
70+

Citations

Study Details | NCT07427628 | A Proof-of-concept Trial to ...

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 ...

TRX103 for Uveitis (PEACOCX Trial)

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 ...

A Proof-of-concept Trial to EvaluAte the efficaCy and Safety ...

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) ...

Tackling challenging indications & unmet medical needs.

TRX103 (Tr1 Treg) ... We focus on diseases with no effective treatment or cure, prioritizing areas where immune tolerance can transform patient outcomes and ...

Tr1X Presents First Clinical Data Demonstrating Proof of ...

The data suggest that TRX103 can address this vulnerability by accelerating immune reconstitution and promoting a tolerogenic environment that ...

A Phase I, First in Human Open Label Study to Evaluate ...

The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies ...

TRX103 / Tr1X

These results build on previously described pharmacology and safety data ... Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis ...