A Phase 2 Study of Lisocabtagene Maraleucel CAR T-Cell Therapy in People With Primary Central Nervous System Lymphoma

Full Title

The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Purpose

Researchers are assessing the cellular therapy lisocabtagene maraleucel (liso-cel) in people with primary central nervous system lymphoma (PCNSL). The people in this study have PCNSL that has not yet been treated. In addition, they cannot have autologous stem cell transplantation (ASCT). During ASCT, a patient’s healthy, blood-forming cells are collected before treatment, stored, and returned after treatment with very strong chemotherapy.

Liso-cel is a form of immunotherapy made from your own white blood cells called T cells. If you take part in this study, we will collect some of your T cells. We will modify them in a lab so they can recognize and destroy your cancer cells. These genetically modified T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T-cell therapies.

While your liso-cel is being made, you may receive rituximab, methotrexate, and procarbazine and/or methotrexate, temozolomide, and rituximab. The purpose of this chemotherapy is to control your disease.

Before you get liso-cel, you will also have chemotherapy with fludarabine and cyclophosphamide to briefly weaken your immune system. This chemotherapy will help prepare your body for liso-cel. The treatments in this study are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

• Have previously untreated PCNSL.
• Not be eligible to receive ASCT.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Michael Scordo’s office at 646-608-3771.