36
Participants
Start Date
January 31, 2012
Primary Completion Date
September 27, 2021
Study Completion Date
September 27, 2027
Antigen-Escalation Stage
"Antigen-Escalation Stage~Each patient will receive 2 injections at the same dose (5 x 10\^6 cells/m2), 28 days apart, according to the following schedules:~Schedule One:~* Day 0: PRAME-specific T cells~* Day 28: PRAME- and SSX-specific T cells~Schedule Two:~* Day 0: PRAME- and SSX-specific T cells~* Day 28: PRAME/SSX/MAGE-specific T cells~Schedule Three:~* Day 0: PRAME/SSX/MAGE-specific T cells~* Day 28: PRAME/SSX/MAGE/NY-ESO specific T cells~Schedule Four:~* Day 0: PRAME/SSX/MAGE/NY-ESO specific T cells~* Day 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells"
Dose-Escalation Stage
"Dose-Escalation Stage~Three different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules:~DL1: Day 0 and Day 14: 5 x 10\^6 cells/m\^2~DL2: Day 0 and Day 14: 1 x 10\^7 cells/m\^2~DL3: Day 0 and Day 14: 2 x 10\^7 cells/m\^2"
azacytidine and multiTAA T cells Stage
"Up to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10\^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following:~1. ANC \>1,000 or Platelets \>50,000 (or any other grade I AE attributable to aza)~ Adjustment: None~2. ANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza)~ Adjustment: 50% dose reduction~3. ANC \<500 or any episode of febrile neutropenia or platelets \<25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza)~Adjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion"
Pediatric multiTAA T cells Stage
Patients \< 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10\^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients.
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
National Cancer Institute (NCI)
NIH
Baylor College of Medicine
OTHER