A Phase I Study of ITIL-306 Immunotherapy in People with Solid Tumors

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Full Title

A Phase 1a/1b, Open-Label, Multicenter Study Evaluating the Safety and Feasibility of ITIL-306 in Subjects with Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy ITIL-306 that can be given safely to patients with metastatic lung cancer, ovarian cancer, or renal cell carcinoma (kidney cancer) that has come back or continued to grow despite treatment. ITIL-306 is a type of therapy called “autologous tumor-infiltrating lymphocytes” (TIL). It is made from white blood cells (lymphocytes or T cells) that come from a piece of a patient’s own tumor removed during surgery. The TILs are developed further in a laboratory, then delivered back to the patient several weeks later. TIL treatments are designed to help the immune system destroy cancer cells. ITIL-306 is given intravenously (by vein).

Eligibility

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

  • Participants must have metastatic non-small cell lung cancer, ovarian cancer, or renal cell carcinoma that has come back or continued to grow despite treatment.
  • Patients must have an accessible tumor lesion that can be removed by surgery to be able to collect the TILs.
  • The serious side effects of previous therapies should go away before ITIL-306 is given.
  • 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 or older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr Adam Schoenfeld at 646-608-4042.

Protocol

22-247

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators