This example study evaluates locoregional allogeneic dual-target mesothelin/FAP CAR-NK cells in adults with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma. Eligible participants must have central confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma. The phase 1 portion defines the recommended phase 2 dose and schedule, and the phase 2 expansion explores preliminary antitumor activity, persistence, and biomarker response in pleural and peritoneal disease cohorts.
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Incidence of dose-limiting toxicities (DLTs) after first CAR-NK infusion
Timeframe: 28 days
ncidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: 12 months
Determination of recommended phase 2 dose and schedule (RP2D/RP2S)
Timeframe: 6 months