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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Quan Dong Nguyen
Study ID
NCT07427628
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Non Infectious Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TRX103 — BIOLOGICAL
    TRX103 infusion via peripheral line

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TRX-103 Inpatient
    Infusion of TRX103 followed by 8 hour in patient observation period
  • Experimental: TRX-103 Outpatient
    Outpatient Infusion of TRX103 followed by outpatient observation period

Primary Outcome Measure

Incidence of Treatment emergent Adverse events and Serious Adverse events at week 52 [ Time Frame: Up to a year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Byers Eye InstitutePalo AltoCalifornia94303
Byers Eye Institute
650-724-8553

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