38
Participants
Start Date
February 28, 2015
Primary Completion Date
January 12, 2024
Study Completion Date
March 31, 2029
MABEL CTLs
"Dose escalation:~DL1:2x10\^7 cells/m2+2x10\^7 cells/m2~DL2:2x10\^7cells/m2+5x10\^7 cells/m2~DL3:5x10\^7 cells/m2+1x10\^8 cells/m2~\*Doses are based on total CD3+cells/m2~Patients with active disease that have apparent clinical benefit at the 8 wk post 1st infusion (6 wks after 2nd infusion) or subsequent evaluations may receive up to 6 additional doses of CTLs at intervals at least 6 wks apart, each of which will consist of the same cell number as their second injection or below the original dose if there is not enough product available for the original dose. Patients may receive lymphodepleting chemotherapy (Cy/Flu) before additional infusions. Patients cannot receive additional doses until the initial safety profile is completed at 6 wks following the second infusion."
Cyclophosphamide
"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."
Fludarabine
"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide and fludarabine before s/he receives MABEL CTLs.~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."
Houston Methodist Hospital, Houston
Texas Children's Hospital, Houston
Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
The Methodist Hospital Research Institute
OTHER
Baylor College of Medicine
OTHER