A Phase I/IIA Study of ATL001 with or without Pembrolizumab Immunotherapy in People with Non-Small Cell Lung Cancer

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Full Title

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)

Purpose

In this study, researchers are assessing the safety of the investigational cellular therapy ATL001 alone and with pembrolizumab immunotherapy in people with advanced or metastatic non-small cell lung cancer (NSCLC).

ATL001 is made in the laboratory using tumor and blood samples collected from a person with NSCLC. Immune cells from the tumor and blood are removed and multiplied. Each patient’s cancer cells are examined to identify unique sets of targets found only on their cancer cells and not on their healthy cells. The final product, ATL001, is made up of a patient’s own immune cells that can recognize those targets and kill the cancer cells. Adding pembrolizumab to ATL001 may make the treatment more effective. Pembrolizumab boosts the power of the immune system to find and destroy cancer cells.

Participants in this study will receive ATL001 alone or with pembrolizumab. Both therapies are given intravenously (by vein).

Eligibility

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

  • Participants must have smoking-related stage IIIB or IV NSCLC.
  • At least 3 weeks must pass since the completion of prior chemotherapy. No prior cellular or gene therapies are permitted.
  • 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.

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

Protocol

21-304

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators