A Phase II Study of MB-CART2019.1 CAR T-Cell Therapy in People with Diffuse Large B-Cell Lymphoma

Full Title

A Multi-Center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects with Relapsed and/or Refractory Diffuse Large B Cell Lymphoma

Purpose

CAR T-cell therapy is a type of immunotherapy used to treat some people with lymphoma that has continued to grow despite prior treatment. The treatment involves using a patient’s own T cells (a type of white blood cell), genetically modifying them in the laboratory to recognize a protein on cancer cells, and multiplying them. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body.

In this study, researchers are evaluating a new type of CAR T-cell therapy called MB-CART2019.1 in people with diffuse large B-cell lymphoma (DLBCL) that continues to grow despite prior treatment. MB-CART2019.1 is designed to target two proteins (CD19 and CD20) on DLBCL cells. This targeting action may help MB-CART2019.1 find cancer cells and kill them.

Participants in this study will receive fludarabine and cyclophosphamide chemotherapy before MB-CART2019.1. This prepares the body for treatment and helps MB-CART2019.1 work better to fight cancer. The treatments in this study are all given intravenously (by vein).

Who Can Join

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

• Participants must have DLBCL that has come back or continued to grow despite at least two prior regimens of treatment that included rituximab and anthracycline.
• Patients must have either experienced return of their disease after autologous stem cell transplant (ASCT) or were not eligible for or consented to ASCT.
• 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. Miguel-Angel Perales at 646-608-3757.