A Phase IA Study of NeoTCR T-Cell Therapy with and without IL-2 in People with Advanced Solid Tumors

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Full Title

A Phase 1a/1b, Open-Label First-in-Human Study of the Safety, Tolerability and Feasibility of Gene-Edited Autologous NeoTCR T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination with Anti-PD-1 to Patients with Locally Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to assess the safety of an investigational immunotherapy called NeoTCR T-cell therapy (NeoTCR-P1) in patients with certain metastatic solid tumors. Patients’ own T cells (white blood cells that are part of the immune system) are removed and sent to a lab to be genetically modified to make NeoTCR-P1, which is designed to attack cancer cells when returned to the patient.

Patients will also receive chemotherapy before the T-cell treatment to prepare the body. Researchers will assess NeoTCR-P1 alone and in combination with interleukin-2 (IL-2), which may further boost the anticancer immune response. All treatments in this study are 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 advanced melanoma, bladder cancer, colorectal cancer, ovarian cancer, breast cancer, non-small cell lung cancer, head and neck cancer, or prostate cancer that cannot be successfully treated with standard therapies.
  • Patients should recover from the serious side effects of previous treatment before receiving the study treatment.
  • 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 about this study and to inquire about eligibility, please contact Dr. Adam Schoenfeld at 646-608-4042.

Protocol

21-002

Phase

I

Disease Status

Relapsed or Refractory

Investigator