{"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":"FG000","title":"MLM-CAR44.1 T-cells Infusion"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Screening Failure"}],"milestones":[{"achievements":[{"comment":"Enrolled patients. Overall, 8 patients were enrolled in the study and underwent the screening phase to evaluate the compliance to the clinical inclusion / exclusion criteria as well as the CD44v6 expression by tumor cells.","groupId":"FG000","numSubjects":"8"}],"type":"STARTED"},{"achievements":[{"comment":"Of the 8 enrolled patients, 2 were treated with MLM-CAR44.1 T-cell at the first dose level.","groupId":"FG000","numSubjects":"2"}],"type":"Treated Patients"},{"achievements":[{"groupId":"FG000","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The recruited patient population, due to the early termination of the clinical study, was made up only of patients affected by multiple myeloma (MM), whereas AML patients were not enrolled.\n\nEight patients, 6 males and 2 females were enrolled in 2 centers. Two patients received the investigational product (MLM-CAR44.1 T-cells), while 6 patients did not. Age ranged from 41 to 66 years, with a median of 56 years.","recruitmentDetails":"The study population originally planned is made up of: Adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory AML or MM expressing CD44v6; Children 1 to 17 years old with AML, only in Phase IIa, except for CZ site. Up to the early termination of the study only adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory MM expressing CD44v6 were recruited"}