36
Participants
Start Date
February 11, 2010
Primary Completion Date
December 6, 2019
Study Completion Date
July 31, 2032
Autologous HER2-specific T cells
Each patient will receive one intravenous injection of autologous HER2-specific T cells at one of the dose levels. If the patient has stable disease or a reduction in the size of the tumor they can receive additional doses of HER2-specific T cells at 6 to 12 weeks intervals-each of which will consist of the same cell number as their HER2-specific T-cell injection. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.
Fludarabine
"Fludarabine will be administered for 5 days prior to the T cells~The dose:~\>10 kg: 25 mg/m2/day;~\<10 kg: 1 mg/kg/day IV over 30 minutes"
Cyclophosphamide
"Cyclophosphamide will be administered for 2 days.~Fludarabine and cyclophosphamide will be given for 2 days, followed by fludarabine alone for the next 3 days, followed by 2 days of rest, before the T cells will be administered.~Cyclophosphamide Dose:~30 mg/kg/day IV over 1 hour (with Mesna and IV hydration)~Fludarabine Dose:~\>10 kg: 25 mg/m2/day; \<10 kg: 1 mg/kg/day IV over 30 minutes"
Autologous CAR Positive T cells
Patient will receive one intravenous injection of autologous CAR T cells at dose level 9C. Further CAR T-cell dose escalation at dose level 9C will be done using the lymphodepletion schema as in dose level 9B.
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
Cancer Prevention Research Institute of Texas
OTHER
Baylor College of Medicine
OTHER