A Phase I Study of GEN-011 Cellular Therapy in People with Advanced Cancers of the Bladder and Kidney

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Full Title

A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors (TITAN)

Purpose

The purpose of this study is to assess the safety of an investigational cellular immunotherapy called GEN-011 in people with advanced cancers of the bladder and kidney. Researchers will also see how the cancer responds to this treatment. GEN-011 is made in a laboratory using a patient’s own white blood cells (lymphocytes). The treatment is designed to attack cancer cells without harming healthy cells. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Patients must have inoperable or metastatic bladder or kidney cancer that cannot be successfully treated with other therapies.
  • Participants should recover from the serious side effects of previous treatments before receiving GEN-011.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.
  • Participants must be able to make multiple trips to Memorial Sloan Kettering in Manhattan for their treatment.

For more information about this study and to ask about eligibility, please contact the office of Dr. David Aggen at 646-422-4679.

Protocol

21-352

Phase

I

Investigator