{"denoms":[{"counts":[{"groupId":"BG000","value":"8"}],"units":"Participants"}],"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":"BG000","title":"MLM-CAR44.1 T-cells Infusion"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"41","upperLimit":"66","value":"56"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"8"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"Czechia"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Confirmed diagnosis of MM","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Patients with relapse or refractory disease","unitOfMeasure":"Participants"}],"populationDescription":"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 (Table 10).\n\nOf the 8 enrolled patients, 2 were treated with MLM-CAR44.1 T-cell at the first dose level. Five patients were screening failures and 1 patient dropped-out before lymphocyte apheresis for fulminant disease progression."}