A Phase I Study of KITE-439 Immunotherapy in Patients with Recurrent or Persistent Cancers that Are the Positive for HPV16 Virus

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Full Title

A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects with Relapsed/Refractory HPV16+ Cancers

Purpose

The purpose of this study is to assess the safety and effectiveness of an investigational icellular mmunotherapy called KITE-439 in patients with recurrent or persistent cancers that are positive for a virus called human papillomavirus 16 (HPV16) and a protein called HLA-A*02:01. KITE-439 is made from T cells, a type of white blood cell. To make the treatment, some of each patient’s T cells are collected and modified in a laboratory to make them recognize and attack tumor cells containing HPV16. The treatment 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 a recurrent or persistent cancer that is positive for HPV16 and HLA-A*02:01.
  • At least 2 weeks must pass between the completion of prior treatments and entry into 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. Christopher A. Klebanoff at 646-888-4888.

Protocol

19-149

Phase

I

Disease Status

Relapsed or Refractory

Co-Investigators