100
Participants
Start Date
March 21, 2025
Primary Completion Date
March 31, 2031
Study Completion Date
March 31, 2032
Phase 1 Dose Level 1
Patients in the first dose level for the CD45RA depleted addback will receive 1 X 10\^6 CD45RO+ T cells/kg. Once all patients in this dose group have been evaluated for acute GVHD at day 100, then we will advance to the next dose level if indicated by safety analysis.
Phase 1 Dose Level 2
Patients in the second dose level for the CD45RA depleted addback will receive 2 X 10\^6 CD45RO+ T cells/kg. Once all patients in this dose group have been evaluated for acute GVHD at day 100, then we will advance to the next dose level if indicated by safety analysis.
Phase 1 Dose Level 3
"Patients in the third and final dose level for the CD45RA depleted addback will receive 5 X 10\^6 CD45RO+ T cells/kg. All patients in this dose group will be evaluated for acute GVHD at day 100. Based on these findings, the maximum tolerated dose (MTD) will be determined.~Once MTD for the addback cell dose has been determined in Phase 1, subjects with mismatched related donors will then enroll in Phase 2."
Phase 2 Maximum Tolerated Dose determined in Phase 1
Patients with mismatched related donors will receive the CD45RA depleted addback at the maximum tolerated dose determined in the Phase 1 portion of the study.
Phase 2 Established Dose from prior study, NCT03810196
Patients with unrelated donors will receive the CD45RA depleted addback at the dose 5 X 10\^6 CD45RO+ T cells.
RECRUITING
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Philadelphia
OTHER