A Phase 1 Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma

Full Title

A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed/Refractory Primary and Secondary Central Nervous System Lymphoma (CNSL) Using On-Site Manufacturing with the CliniMACS Prodigy Device

Purpose

Researchers are finding the best dose of MB-CART19.1 immunotherapy in people with lymphoma. The people in this study have central nervous system lymphoma (CNSL) that came back or keeps growing after treatment.

MB-CART19.1 is a cellular therapy made from your own white blood cells (called T cells). We will collect some of your T cells and modify them in a lab to recognize and destroy cancer cells. Then we will give them back to you. These modified T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T-cell therapies.

Before you get MB-CART19.1, you will have chemotherapy with fludarabine and cyclophosphamide to briefly weaken your immune system. This chemotherapy will help prepare your body for MB-CART19.1. 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 primary or secondary CNSL that came back or keeps growing after treatment.
  • Not have previously had CAR T-cell therapy for CNSL.
  • 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 and to see if you can join this study, please call Dr. Christian Grommes’ office at 212-610-0344.

Protocol

25-066

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT07137494