TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

March 31, 2017

Study Completion Date

February 28, 2033

Conditions
EBV-positive Nasopharyngeal Carcinoma
Interventions
BIOLOGICAL

DNR.NPC-specific T cells

"Each patient will receive 2 infusions, 14 days apart, according to the following dosing schedule:~Dose Level 1:~Day 0: 2 x 10\^7 cells/m\^2~Day 14: 2 x 10\^7 cells/m\^2~The doses are calculated according to the total T cell number."

BIOLOGICAL

DNR.NPC-specific T cells + cyclophosphamide + fludarabine

"Patients will receive cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.~Each patient will receive infusions according to the following dosing schedule:~Dose Level 2:~Cy/Flu on Days -4 to -2 and then 4 x 10\^7 cells/m\^2 on Day 0, Day 1 or Day 2~Dose Level 3:~Cy/Flu on Days -4 to -2 and then 1 x 10\^8 cells/m\^2 on Day 0, Day 1, or Day 2"

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

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