Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- Determine the safety and maximum tolerated dose of T cells activated in vitro and
modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients
with CEA expressing adenocarcinoma.
- Determine the pharmacokinetics of this regimen by the persistence of modified T cells
in the blood of these patients.
- Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
- Assess immunologic parameters which correlate with the efficacy of this regimen in
- Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA
OUTLINE: This is a dose escalation study.
Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then
modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR
modified T cells are reinfused over 30-60 minutes.
The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients
experience unacceptable toxicity. If the MTD is not reached within the first cohort, a
second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.
Patients are followed every 2 weeks for 2 months.
PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.
Primary Purpose: Treatment
Richard P. Junghans, MD, PhD
Beth Israel Deaconess Medical Center
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|