Treatment of Moderate to Severe Refractory Crohn's Disease

Inclusion Criteria: 1. Male and females ≥ 18 and ≤ 65 years of age at time of consent. 2. Weight of ≥ 40 kg. 3. Medical history and biological evidence of active bowel inflammation documented by: * Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and; * Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader) 4. Active disease defined as moderate to severe active CD at Screening defined by all of the following: * Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and; * CDAI total scores ≥ 220 5. Subject on treatment with corticosteroids may be included if they meet the following: * prednisone or equivalent dose ≤ 20 mg/day; or * budesonide ≤ 9 mg/day; or * has been on a stable dose for at least 7 days prior to TRX103 dose. 6. Advanced therapy-refractory disease defined by: Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following: * TNF-alpha inhibitors * IL-12/23 inhibitors * Anti-integrins * JAK inhibitors Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD. * Primary failure is defined as: * When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks. * A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment. * Secondary failure, or relapse defined as: * Subjects who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment. * Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \> 220, and/or SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment. * Intolerant to therapy, defined as: * When a subject is unable to cope with the side effects or mechanism of actions of the treatment and/or experiences unacceptable side effects when dosed at appropriate therapeutic levels. 7. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment. 8. Subjects must be able to understand and sign informed consent and be willin…