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P12-2 (STRIDE; NCT01981122) is an ongoing, randomized, Phase II, open-label study evaluating concurrent vs sequential administration of the androgen receptor inhibitor, enz, with the autologous cellular immunotherapy, sip-T. The primary aim of this study is to determine if the order of sip-T and enz administration impacts immune responses to the immunizing antigen, PA2024, of sip-T.
Patients with asymptomatic or minimally symptomatic mCRPC were randomized 1:1 to receive 3 sip-T infusions with enz starting 2 weeks (wks) before (n=25, concurrent arm A) or 10 wks after (n=27, sequential arm B) sip-T initiation. Antigen-specific cellular and humoral immune responses were evaluated via interferon (IFN)-γ ELISPOT, cell proliferation, and antibody ELISA assays. In addition, the breadth of the humoral response to non-target antigens was also studied.
T cell proliferative responses to PA2024 were significantly elevated at all post-baseline time points (p < 0.001) and were sustained through wk 26, including a >10-fold increase at wk 20 in both arms. Both arms showed a significant and sustained increase in IFN-γ ELISPOT response to PA2024 and humoral responses to PA2024 and PAP. Broadening of the humoral responses to non-target antigens PSA, LGALS3, LGALS8, KRAS, ERAS and KLK2 at all post-treatment time points was observed in both arms. Cytokines indicative of immune activation (including IFN-γ, interleukin-2, and tumor necrosis factor-α) were also elevated in both arms, at the 2nd and 3rd sip-T infusions. Adverse events were similar between arms.
Treatment of mCRPC subjects with enz administered concurrently with or subsequent to sip-T resulted in significant and sustained peripheral antigen-specific T cell and humoral immune responses through wk 26. Both treatment schedules led to similarly robust humoral antigen spread sustained through wk 26. These data suggest enz did not affect sip-T production, subsequent immune responses, or safety.
ClinicalTrials.gov identifier NCT01981122.