{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"Safety will be evaluated by analyzing the type, frequency and severity of adverse events (AE) and by monitoring for systemic reactions (fever, tachycardia, nausea and vomiting, joint pain, skin rash).\n\nOverall, 3 study emergent serious adverse events (SAEs) were reported in patients treated with MLM-CAR44.1 T-cells.","groups":[{"description":"Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3\n\nThe dose of iv infused MLM-CAR44.1 T-cells is:\n\nPHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).","id":"OG000","title":"MLM-CAR44.1 T-cells Infusion"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"For 30 days following CAR T-cell infusion, assessed as day 0.","title":"Phase I: Overall Safety of Treatment With MLM-CAR44.1 T-cells","type":"PRIMARY","unitOfMeasure":"Number of SAEs"}