{"classes":[{"title":"Baseline"},{"title":"Prior to chemotherapy"},{"title":"2 weeks after final T-cell infusion"},{"title":"1 month after final T-cell infusion"},{"title":"2 months after final T-cell infusion"},{"title":"3 months after final T-cell infusion"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}],"units":"Participants"}],"description":"Immune reconstitution in recipients of Th1.rapa cells was determined by flow cytometry.","groups":[{"description":"1x10(5) Th1/Tc1.Rapa cells/kg of body weight","id":"OG000","title":"Cohort 1 - 1x10(5) T Cells/kg"},{"description":"5x10(5) Th1/Tc1.Rapa cells/kg of body weight","id":"OG001","title":"Cohort 2 - 5x10(5) T Cells/kg"},{"description":"1x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG002","title":"Cohort 3 - 1x10(6) T Cells/kg"},{"description":"3x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG003","title":"Cohort 4 - 3x10(6) T Cells/kg"},{"description":"5x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG004","title":"Cohort 5 - 5x10(6) T Cells/kg"},{"description":"5x10(6) Th1 rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.","id":"OG005","title":"Cohort 5B - 5x10(6) Th1 Rapa Cells/kg"},{"description":"15x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG006","title":"Cohort 6 - 15x10(6) T Cells/kg"},{"description":"45x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG007","title":"Cohort 7 - 45x10(6) T Cells/kg"},{"description":"Th1/Tc1.Rapa Prevention of Relapse\n\nAdoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).\n\nRapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.\n\nTh1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg","id":"OG008","title":"Cohort A - Th1/Tc1.Rapa Prevention of Relapse"},{"description":"Th1/Tc1.Rapa for Relapsed Multiple Myeloma\n\nAdoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).\n\nTh1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg","id":"OG009","title":"Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma"}],"populationDescription":"For the planned protocol cohort 7, no pts were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. # that could be manufactured due to limiting reagents for cell culture. Outcome measure not done; data not collected in real-time due to premature closure of study.","reportingStatus":"POSTED","timeFrame":"Baseline, prior to chemotherapy, and 2 weeks, 1, 2, and 3 months after final T cell infusion","title":"Immune Reconstitution in Recipients of Th1.(T Helper Cell) Rapa Cells.","type":"SECONDARY"}