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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.
Aim:
The aim of this study was to determine the immunologic effects and safety of oral anti-CD3 in patients with ulcerative colitis (UC).
Methods:
An open-label pilot study of orally delivered anti-CD3 was performed in patients with moderate-to-severe UC. The primary end points were changes in immunologic parameters and evaluation for safety.
Results:
Six subjects received oral OKT3. Biologic effects of oral anti-CD3 included significantly increased proliferation in response to anti-CD3 and anti-inflammatory gene expression profile in peripheral blood mononuclear cells. No serious treatment-related adverse events occurred.
Conclusion:
Orally delivered anti-CD3 resulted in immunologic changes in patients with UC.
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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