Immunologic Alterations Associated With Oral Delivery of Anti-CD3 (OKT3) Monoclonal Antibodies in Patients With

Elisa K Boden1,2, James B Canavan3,4,5, Christopher J Moran6,7

  • 1Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.

Crohn'S & Colitis 360
|August 20, 2019
PubMed
Abstract

Insights

Oral anti-CD3 therapy in ulcerative colitis (UC) patients showed significant immunologic changes, including increased cell proliferation and anti-inflammatory gene expression. This pilot study found no serious adverse events, suggesting potential for oral immunotherapy in UC treatment.

Area of Science:

  • Immunology
  • Gastroenterology
  • Pharmacology

Background:

  • Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
  • Current treatments for UC have limitations and side effects.
  • Targeting immune pathways is a key strategy for UC treatment.

Purpose of the Study:

  • To investigate the immunologic effects of orally administered anti-CD3 therapy.
  • To assess the safety profile of oral anti-CD3 in patients with moderate-to-severe UC.
  • To explore the potential of oral anti-CD3 as a novel therapeutic approach for UC.

Main Methods:

  • An open-label pilot study was conducted.
  • Moderate-to-severe UC patients received orally delivered anti-CD3 (OKT3).
  • Immunologic parameters and safety were monitored as primary endpoints.

Main Results:

  • Six subjects completed the oral anti-CD3 treatment.
  • Significant increases in peripheral blood mononuclear cell proliferation in response to anti-CD3 were observed.
  • An anti-inflammatory gene expression profile was noted.
  • No serious treatment-related adverse events were reported.

Conclusions:

  • Oral anti-CD3 administration induced measurable immunologic changes in UC patients.
  • The observed immunologic effects suggest a potential therapeutic mechanism.
  • Oral anti-CD3 appears to be safe in this small pilot cohort, warranting further investigation.

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