HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2033

Conditions
Human Papillomavirus-Related CarcinomaHuman Papillomavirus Positive Oropharyngeal CarcinomaHuman Papillomavirus Positive Cervical CarcinomaHuman Papillomavirus Positive Anal CarcinomaHuman Papillomavirus Positive Vulvar CarcinomaHuman Papillomavirus Positive Penile Carcinoma
Interventions
GENETIC

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."

DRUG

Cytoxan

500mg/m\^2/day x 3 days (on days -4, -3 and -2)

DRUG

Fludarabine

30mg/m\^2/day x 3 days (on days -4, -3, and -2)

BIOLOGICAL

Nivolumab

240mg every 2 weeks (+/- 3 days) starting on day -1

Trial Locations (1)

77030

Houston Methodist Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

lead

Baylor College of Medicine

OTHER