{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"The absence of replication competent retrovirus (RCR) in blood specimens will be monitored by DNA PCR for the Galv gene.\n\nRCR search was conducted centrally using a quantitative molecular test, (real time quantitative PCR, q-PCR analysis) determining the absence of RCR by DNA PCR for the Galv and gag-pol genes on genomic DNA from patient's peripheral blood lymphocytes. The objective of this q-PCR analysis is to exclude the presence of RCR originated by recombination with PG13 packaging cell sequences by detecting the Galv and gag-pol transcripts in the transduced cells. The absence of the Galv and gag-pol transcripts can exclude the presence of an RCR, while its presence is not sufficient to indicate the presence of an RCR, and in this case further analysis is required","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":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"6 months after infusion (assessed as day 0)","title":"Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 6 Months Post-infusion","type":"PRIMARY","unitOfMeasure":"Participants"}