On Day 3 after injection of TTI-621, the patient noted a 20% reduction in the size of the injected tumor. There was a decrease in the percentage of Sézary cells (CD4+CD26-) in the peripheral blood from 56.2% before injection of TTI-621 to 26.9% on Day 3 and 5.8% on Day 5. These changes were accompanied by a transient increase in CD11b+CD14+ macrophages in the peripheral blood from 3.9% before injection to 6.1% on Day 3, which returned to baseline by Day 7. The administration of PEGylated Interferon-a2a on day 7 after TTI-621 decreased the Sézary cell count from 52.5% to 0.62% on day 14, which was accompanied by an improvement in erythroderma as well as the resolution of dysesthesia of the skin that patient experienced at baseline. A significant increase in the percentage of NK cells (CD56+CD3-) and naïve CD8+ cells (CCR7+CD45RO-) was observed following injection of TTI-621 by day 7, and also observed 7 days after PEGylated Interferon-a2a. One week following the injection of PEGylated Interferon-a2a, all tumors had regressed completely.
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