- |||||||||| NIB102 - Noile / Immune Biotech
Quantitative clinical pharmacology and mechanistic modeling of TAK-102, a GPC3 targeted CAR-T therapy armored with IL-7 and CCL19, in a phase-1 clinical trial in solid tumor patients (Grand Ballroom AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1766;
P1
Methods As of March 31st, 2024, 11 patients have been infused with TAK-102 at dose-levels of 10 million (DL1), 100 million (DL2) and 500 million (DL3) CAR+ cells/patient after standard lymphodepletion chemotherapy regimen of cyclophosphamide and fludarabine...Results Among the 11 patients treated so far, no DLT or neurotoxicity was observed, whereas 6/11 patients experienced mild cytokine release syndrome (CRS, mostly grade 1) managed by appropriate medications (e.g., tocilizumab), suggesting acceptable safety profile of TAK-102...A mechanistic PBCK-PD model was able to adequately integrate dataset(s) pertaining to extent of lymphodepletion, homeostatic cytokines, TAK-102 CK, tumor volume and key biomarker measurements by goodness of fits. Conclusions The integrated CK-PD analysis presented here could facilitate identification of relative contribution of factors impacting exposure/response of TAK-102 and help understand the mechanism of action of this therapy to further enable future dose-optimization.
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Quantitative clinical pharmacology and mechanistic modeling of TAK-102, a GPC3 targeted CAR-T therapy armored with IL-7 and CCL19, in a phase-1 clinical trial in solid tumor patients (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_874;
P1
Methods As of March 31st, 2024, 11 patients have been infused with TAK-102 at dose-levels of 10 million (DL1), 100 million (DL2) and 500 million (DL3) CAR+ cells/patient after standard lymphodepletion chemotherapy regimen of cyclophosphamide and fludarabine...Results Among the 11 patients treated so far, no DLT or neurotoxicity was observed, whereas 6/11 patients experienced mild cytokine release syndrome (CRS, mostly grade 1) managed by appropriate medications (e.g., tocilizumab), suggesting acceptable safety profile of TAK-102...A mechanistic PBCK-PD model was able to adequately integrate dataset(s) pertaining to extent of lymphodepletion, homeostatic cytokines, TAK-102 CK, tumor volume and key biomarker measurements by goodness of fits. Conclusions The integrated CK-PD analysis presented here could facilitate identification of relative contribution of factors impacting exposure/response of TAK-102 and help understand the mechanism of action of this therapy to further enable future dose-optimization.
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Trial completion date, Trial primary completion date: TAK-102-1501: A Study of TAK-102 in Adult With Previously-Treated Solid Tumors (clinicaltrials.gov) - Jul 31, 2024
P1, N=11, Active, not recruiting,
Conclusions The integrated CK-PD analysis presented here could facilitate identification of relative contribution of factors impacting exposure/response of TAK-102 and help understand the mechanism of action of this therapy to further enable future dose-optimization. Trial completion date: Dec 2026 --> Jul 2026 | Trial primary completion date: Dec 2026 --> Jul 2026
- |||||||||| TAK-102 / Takeda
Development and application of physiologically based pharmacokinetic (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_612;
Conclusions The developed model was able to describe the observed data, while accounting for tumor heterogeneity of CAR-T cells, impact of lymphodepletion regimen on CAR-T expansion and target-mediated expansion of effector CAR-T cells. Using model simulations, CAR-T expansion was found to be driven by initial tumor burden and GPC3 expression.
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Trial completion date, Trial primary completion date: TAK-102-1501: A Study of TAK-102 in Adult With Previously-Treated Solid Tumors (clinicaltrials.gov) - Mar 24, 2023
P1, N=18, Recruiting,
Using model simulations, CAR-T expansion was found to be driven by initial tumor burden and GPC3 expression. Trial completion date: Jul 2023 --> Dec 2026 | Trial primary completion date: Jul 2023 --> Dec 2026
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