A Phase I Study of AUTO3 CAR T-Cell Therapy with Pembrolizumab Immunotherapy in People with Recurrent or Persistent Diffuse Large B-Cell Lymphoma

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Full Title

A Single-Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, A CAR T Cell Treatment Targeting CD19 and CD22 with Anti PD-1 Antibody in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Purpose

In this study, researchers are assessing the best dose of an investigational CAR T-cell therapy when given in combination with pembrolizumab immunotherapy in patients with diffuse large B-cell lymphoma (DLBCL) that has come back or continued to grow despite treatment. CAR T-cell therapy is a form of treatment made of a patient’s own immune cells called T cells, which are removed from the body, genetically modified in a laboratory to recognize and attach to cancer cells, multiplied, and returned to the patient to fight cancer.

The conventional CAR T-cell therapy used to treat recurrent or persistent DLBCL targets one protein on cancer cells. The CAR T-cell therapy being evaluated in this study, called AUTO3, targets two proteins: CD19 and CD22. Researchers think AUTO3 may therefore prevent lymphoma cells from escaping or avoiding being killed, which can happen with standard CAR T-cell therapy.

Pembrolizumab may help make AUTO3 more effective and last longer in the body. It boosts the power of the immune system to detect and destroy cancer cells. The 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 DLBCL that came back or continued to grow despite prior treatment. Prior immunotherapy is not permitted.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • 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 the office of Dr. Anas Younes at 212-639-7715.

Protocol

20-010

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators