A Phase IB Study of Armed, Activated T Cells in Patients with Advanced Pancreatic Cancer

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Full Title

MCT: Phase Ib Treatment of Advanced Pancreatic Cancer with anti-CD3 x anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)

Purpose

The purpose of this study is to find the safest dose and identify side effects of the investigational treatment EGFR-BATs in people with advanced pancreatic cancer who have already received initial standard chemotherapy. EGFR-BATs (“bispecific antibody-armed activated T cells”) is created from a patient’s own immune cells (T cells, a type of white blood cell) coated (“armed”) with another investigational drug made up of the bispecific antibodies cetuximab and OKT3.

The EGFR-BATs antibody targets a molecule called EGFR on pancreatic cancer cells and uses the body’s immune system to destroy cancer cells. Cetuximab and OKT3 are used to suppress the immune system to prevent the body from reacting to the EGFR-BATs treatment. EGFR-BATs is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic cancer and have received at least one prior regimen of chemotherapy. Patients’ cancers must have grown during or within 6 months of treatment.
  • Patients should recover from the serious side effects of treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Kenneth Yu at 646-888-4188.

Protocol

18-463

Phase

I

Disease Status

Relapsed or Refractory

Investigator