Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 11, 2010

Primary Completion Date

December 6, 2019

Study Completion Date

July 31, 2032

Conditions
Sarcoma
Interventions
GENETIC

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.

DRUG

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"

DRUG

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"

GENETIC

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.

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Cancer Prevention Research Institute of Texas

OTHER

lead

Baylor College of Medicine

OTHER

NCT00902044 - Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma | Biotech Hunter | Biotech Hunter