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• W2949774890 abstract "Background: Interleukin-2-Inducible T-Cell Kinase (ITK) is a Tec‑family, non‑receptor tyrosine kinase expressed in T cells that plays a key role in T-cell receptor (TCR) signaling, which is required for development of T-cells. In T-cell lymphoproliferative disorders, expression of the TCR and its downstream signaling components are maintained, which suggests that malignant cells may exploit this growth and survival pathway to their advantage. Professional antigen‑presenting cells abundant in the lymphoma microenvironment may provide antigen to drive TCR signaling through ITK, which is expressed in a variety of T-cell lymphomas including PTCL, CTCL, ALCL, and in a subgroup of T‑lymphoblastic leukemia/lymphoma. CPI-818 is a first-in-class, irreversible, covalent-binding ITK inhibitor with a high degree of selectivity for ITK. By inhibiting ITK, CPI-818 blocks signaling pathways that are essential to inflammatory responses and has shown to inhibit tumor growth in animal models. To test this clinically, a phase 1/1b dose-escalation trial of CPI-818 is initiated in subjects with relapsed/refractory T-cell lymphoma. Methods: The trial will include patients with various types of T-cell lymphoma (PTCL and CTCL) who have progressed on, refractory to, relapsed, or intolerant to at least 2 standard therapies; age ≥18 yo; have ECOG status 0-1; adequate organ function; and without any other condition that would contraindicate the use of the investigational product. Dose Escalation with 3 + 3 (+ optional 3) design will consist of up to 6 ascending dose levels (100,200, 400, 600, 900, and 1200 mg BID) of CPI-818. In the Dose Expansion phase, there will be 4 disease-specific expansion cohorts (AITL, PTCL-NOS, CTCL and other T-cell lymphoma), and each cohort may enroll up to a maximum of 28 subjects/cohort based on a 2‑stage expansion design- Figure. The objectives of the study are to evaluate the safety and tolerability of CPI-818; establish the maximum tolerated dose or the maximum administered dose of CPI-818; evaluate pharmacokinetics and pharmacodynamics of CPI-818 in humans; assess the anti-tumor activity of CPI-818 and identify potential biomarker signals. Study schema in the figure. Keywords: cutaneous T-cell lymphoma (CTCL); peripheral T-cell lymphomas (PTCL); T-cell lymphoma (TCL). Disclosures: Mobasher, M: Employment Leadership Position: Chief Medical Officer." @default.
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• W2949774890 date "2019-06-01" @default.
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• W2949774890 title "A PHASE 1/1B DOSE-ESCALATION TRIAL EVALUATING CPI-818, AN ORAL INTERLEUKIN-2-INDUCIBLE T-CELL KINASE INHIBITOR, IN PATIENTS WITH RELAPSED/REFRACTORY T-CELL LYMPHOMA" @default.
• W2949774890 doi "https://doi.org/10.1002/hon.11_2632" @default.
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