A Phase I Study of KITE-718 Immunotherapy: T Cells Modified to Recognize the MAGE-A3/A6 Protein in Patients with Advanced Cancer

Full Title

A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects with Advanced Cancers

Purpose

The purpose of this study is to evaluate the safety and preliminary effectiveness of an investigational immunotherapy called KITE-718. This treatment is comprised of immune cells called T cells which have been removed from the patient, modified in the laboratory to recognize a protein called MAGE-A3/A6, multiplied, and then returned to the patient to find and kill cancer cells. MAGE-A3/A6 is present inside the cancer cells of some patients with advanced cancer.

Before receiving KITE-718 therapy, patients receive chemotherapy to “make space” in the body to accommodate the KITE-718 cells. After receiving KITE-718, they’ll receive other medications to support the growth of white blood cells. The chemotherapy and KITE-718 are given intravenously (by vein), and the medications used afterward are given as subcutaneous (under the skin) injections.

Eligibility

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

  • Patients must have an advanced cancer that has come back or is continuing to grow despite one or more prior treatments.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients’ tumors must contain the MAGE-A3/A6 protein. Testing for this protein will be done during the prescreening part of the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 about this study and to inquire about eligibility, please contact the Immunotherapeutics referral team at 646-888-4593.

Protocol

17-347

Phase

I

Co-Investigators