A Phase I Study of NL-201 Immunotherapy in People with Recurrent or Persistent Solid Tumors

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Full Title

A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug NL-201 that can be given safely in people with solid tumor cancers that have continued to grow or came back despite prior treatment.

NL-201 activates the immune system to fight cancer by attaching to two proteins on the surface of cancer cells called IL-2 and IL-15. These proteins promote the growth of T cells and NK (natural killer) cells, which are white blood cells that play a role in the immune response. When NL-201 binds to IL-2 and IL-15, it triggers T cells and NK cells to target and kill cancer cells. NL-201 is given intravenously (by vein).

Eligibility

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

  • Participants must have a solid tumor that has continued to grow despite prior treatment. People with prostate cancer are not eligible for this study.
  • Prior treatment with IL-2-directed treatment, CAR T-cell therapy, or other cellular therapy is not permitted.
  • 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, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Margaret Callahan at 646-888-5108.

Protocol

21-332

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators