Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer)
Summary
The purpose of this research study is for the participant to give their own T cells (a type of blood cell in the body that can fight infections and possibly cancer) to them after they have been removed, grown in a lab, and then coated with an experimental drug. This study will determine the highest dose of EGFR2Bi coated T cells that can be given without causing severe side effects. Initially a group of 3 participants will receive the same dose of study drug. If no serious side effects occur, the next group of participants will receive a slightly higher dose of study agent. The following groups of participants will receive higher doses of the study drug until a dose is reached where there are unacceptable side effects and maximum tolerated dose is found, or the planned highest dose level is reached with no side effects.
Timeline
- Start
- 2011-08-17
- Primary completion
- 2020-10-19
- Completion
- 2020-10-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EGFRBi armed ATC Infusions | Cell therapy | 5e+09 cells | Intravenous |
| Subject | EGFRBi armed ATC Infusions | Cell therapy | 1e+10 cells | Intravenous |
| Subject | EGFRBi armed ATC Infusions | Cell therapy | 2e+10 cells | Intravenous |
| Subject | EGFRBi armed ATC Infusions | Cell therapy | 4e+10 cells | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 unknown | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |