MSLN-TTC showed good tolerability, but the maximum tolerated dose could not be determined due to discontinuations after antidrug antibody formation. Stable disease was observed in 12 out of 36 patients.
Model was developed based on digitized individual level CK, categorical antitumor activity and percentage tumor antigen expression dataset from following phase-1 dose-escalation studies: (A) anti-mesothelin CAR-T in multiple cancer indications (n = 15, cohorts w/ and w/o LDC), (B) gavocabtagene autoleucel (n = 7, w/ and w/o LDC) in multiple indications, (C) anti-glypican 3 CAR-T in advanced hepatocellular carcinoma (n = 13, dose-range 0.7-5.18 billion) and (D) anti-PSMA/TGFβ CAR-T in prostate cancer (n = 10, w/ and w/o LDC)...Using model simulation, CAR-T cell expansion was found to be dependent on initial tumor burden and antigen positive tumor fraction. The developed PBPK-PD model could be leveraged as an effective tool in future to provide mechanistic understanding on CK-PD behavior of cell therapies targeting solid tumors.
P1, N=9, Terminated, Fred Hutchinson Cancer Center | Trial completion date: Sep 2025 --> Jan 2025 | Active, not recruiting --> Terminated; Study terminated due to end of funding.
8 months ago
Trial completion date • Trial termination
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HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
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cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ