A Phase 1 Study of a New CAR T Cell Therapy for People With Recurrent or Persistent Large B-Cell Lymphoma

Full Title

A Phase I Study of T-cell receptor alpha constant (TRAC) Locus Integrated CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients with CD19+ Relapsed or Refractory Large B-Cell Lymphoma

Purpose

This study is evaluating the safety of a new form of CAR T cell therapy for people with B-cell lymphoma that has continued to grow or came back after prior treatment. With CAR T cell therapy, some of a patient’s own T cells (a type of white blood cell) are removed and genetically modified in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body. This approach is a form of immunotherapy.

The CAR T cell therapy being assessed in this study is called 19(T2)28z1xx TRAC. The modified T cells recognize a protein on cancer cells called CD19. There are other forms of CAR T cell therapy that recognize CD19. However, due to the specific way the genes are made into the 19(T2)28z1xx TRAC-CAR T cells, the CAR T cells used in this study may help shrink or stabilize cancer for a longer period of time following treatment.

Before patients receive 19(T2)28z1xx CAR T cells, they will receive “conditioning” chemotherapy with either bendamustine or fludarabine and cyclophosphamide to suppress the immune system and help prepare the body to receive the CAR T cells. The treatments in this study are given intravenously (by vein).

Who Can Join

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

• Participants must have diffuse large B-cell lymphoma or large B-cell lymphoma that came back or continued to grow despite treatment.
• Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for patients age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact Dr. Jae Park at 646-608-3743.