32
Participants
Start Date
September 30, 2015
Primary Completion Date
October 31, 2025
Study Completion Date
October 31, 2033
HPV Specific T Cells
"Dose escalation study with 5 dose levels: DL1-1×10\^7 cells/m2, DL2-3×10\^7 cells/m2, and DL3-1×10\^8 cells/m2, DL4- 2 to 3×10\^8 cells/m2, DL5- 0.8 to 1×10\^9 cells/m2~Group A -HPVST cells Group B -lymphodepletion \& nivolumab \& HPVST cells.~First, treatment in Group A will be completed for DL1 and DL2. Only if DL2 in Group A proves safe, Group B will be treated on DL2, DL3, DL4, and DL5.~Group A will be treated at DL3, DL4, and DL5 only if there is excessive toxicity in cohorts treated with lymphodepletion.~HPVSTs will be given by IV injection over 1-10 minutes through a peripheral or a central line on day 0.~If patients have clinical benefit (as determined by symptoms, physical exam or radiological studies) \& no significant toxicities, they may get up to 5 repeat infusions (for max total of 6 infusions) of HPVSTs at or below the same dose level."
Cytoxan
500mg/m\^2/day x 3 days (on days -4, -3 and -2)
Fludarabine
30mg/m\^2/day x 3 days (on days -4, -3, and -2)
Nivolumab
240mg every 2 weeks (+/- 3 days) starting on day -1
Houston Methodist Hospital, Houston
Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
The Methodist Hospital Research Institute
OTHER
Baylor College of Medicine
OTHER