drugset / Trial / NCT01420874

Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer)

NCT01420874 ↗

Phase 1 Completed 15 enrolled Barbara Ann Karmanos Cancer Institute
NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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