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Treatment of Moderate to Severe Refractory Crohn's Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by Tr1X, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Male and females ≥ 18 and ≤ 65 years of age at time of Screening
2. Weight of ≥ 40 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until 12 months post trx103 infusion.
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Crohn's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until 12 months post trx103 infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 12 months post trx103 infusion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.
Secondary study objectives
Improvement in Patient Reported Outcomes (PRO).
Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD Score).
Improvement of CD status.
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 3AExperimental Treatment2 Interventions
Dose level 3 with conditioning
Group II: Cohort 3Experimental Treatment1 Intervention
Dose level 3
Group III: Cohort 2AExperimental Treatment2 Interventions
Dose level 2 with conditioning
Group IV: Cohort 2Experimental Treatment1 Intervention
Dose level 2
Group V: Cohort 1Experimental Treatment1 Intervention
Dose level 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

Tr1X, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
~15 spots leftby Dec 2025
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