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    11ms
    Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> Apr 2026
    Trial completion date • Combination therapy
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    Calquence (acalabrutinib) • ACP-319
    over1year
    ACE-CL-002: Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> May 2026
    Trial completion date • Combination therapy
    |
    Calquence (acalabrutinib) • ACP-319
    over2years
    Intermittent PI3Kδ inhibition sustains anti-tumour immunity and curbs irAEs. (PubMed, Nature)
    Here we assessed the effects of the PI3Kδi AMG319 in human patients with head and neck cancer in a neoadjuvant, double-blind, placebo-controlled randomized phase II trial (EudraCT no...Single-cell RNA-sequencing analysis revealed a PI3Kδi-driven loss of tissue-resident colonic ST2 T cells, accompanied by expansion of pathogenic T helper 17 (T17) and type 17 CD8 T (T17) cells, which probably contributed to toxicity; this points towards a specific mode of action for the emergence of irAEs. A modified treatment regimen with intermittent dosing of PI3Kδi in mouse models led to a significant decrease in tumour growth without inducing pathogenic T cells in colonic tissue, indicating that alternative dosing regimens might limit toxicity.
    Journal
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    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
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    ACP-319