Treatment of Moderate to Severe Refractory Crohn's Disease

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Tr1X, Inc.
Study ID
NCT06721962
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • TRX103 — BIOLOGICAL
    TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
  • Cyclophosphamide — DRUG
    Low dose cyclophosphamide conditioning.

Study Details

This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.

Key Dates

Start date
May 5, 2025
Status verified
Dec 2025
Primary completion
Jan 30, 2026
Completion
Jan 30, 2027

Study Design

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

Arms

  • Experimental: Cohort 1
    Dose level 1
  • Experimental: Cohort 2
    Dose level 2
  • Experimental: Cohort 2A
    Dose level 2 with conditioning
  • Experimental: Cohort 3
    Dose level 3
  • Experimental: Cohort 3A
    Dose level 3 with conditioning

Primary Outcome Measure

To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease. [ Time Frame: From baseline until 12 months post TRX103 infusion. ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Study Coordinator
[email protected]
480-301-6373
University of California, DavisSacramentoCalifornia95817
Clinical Research Supervisor
[email protected]
(916) 734-0753
University of California, San FranciscoSan FranciscoCalifornia94158
Study Coordinator
[email protected]
(415) 514-1170
University of FloridaGainesvilleFlorida32608
Study Coordinator
[email protected]
352-273-9483
NorthwesternChicagoIllinois60611
Study Coordinator
[email protected]
312-695-5878
University of ChicagoChicagoIllinois60637
Clinical Trial Manager
[email protected]
773-834-7414
University of IowaIowa CityIowa52242
Study Coordinator
[email protected]
319-467-4169
University of LouisvilleLouisvilleKentucky40202
Study Coordinator
[email protected]
502-852-6993
University of MichiganAnn ArborMichigan48109
Clinical Trial Manager
[email protected]
734-615-4843
Mayo Clinic RochesterRochesterMinnesota55905
Study Coordinator
[email protected]
507-266-4728
Washington University in St. LouisSt LouisMissouri63110
Study Coordinator
[email protected]
314-273-0301
Mount Sinai Health SystemsNew YorkNew York10029
Study Coordinator
[email protected]
(929) 641-0917
Cleveland ClinicClevelandOhio44195
Study Coordinator
[email protected]
440-523-8503

Find similar trials in Scottsdale, AZ

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Mayo Clinic Arizona· Scottsdale, AZUniversity of California, Davis· Sacramento, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Florida· Gainesville, FLNorthwestern· Chicago, ILUniversity of Chicago· Chicago, IL

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