This phase I trial studies the side effects and best dose of MB-CART19.1 cellular therapy in treating patients with central nervous system (CNS) lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). MB-CART19.1 is a cellular therapy that is made from a patient's own white blood cells (called T cells). T cells are immune system cells that protect the body from infections, cancer, and other possible harms. Some types of cancer can block T cells from attacking the cancer cells. MB-CART19.1 is made by collecting patient T cells and adding a gene (a small piece of deoxyribonucleic acid [DNA]) from a virus, which helps the T cells recognize and destroy the cancer cells. These genetically changed (modified) T cells are called chimeric antigen receptor (CAR) T cells, and treatments made from them are called CAR T-cell therapies. MB-CART19.1 may be safe in treating patients with relapsed or refractory CNS lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT07137494.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Ivan Kotchetkov
Phone: 212-610-0751
PRIMARY OBJECTIVE
I. To assess the safety and tolerability of administering autologous CD19 CAR-expressing CD4+/CD8+ T-cells MB-CART19.1 (MB-CART19.1) in patients with relapsed or refractory primary or secondary central nervous system lymphoma (CNSL) and identify a maximum tolerated dose (MTD) to be used in a future phase II study.
SECONDARY OBJECTIVES:
I. To assess leukapheresis to infusion time.
II. To assess the clinical response to MB-CART19.1 with the following measures:
IIa. Overall response rate (ORR);
IIb. Overall survival (OS);
IIc. Duration of response (DOR);
IId. Progression free survival (PFS);
III. To assess the in vivo persistence of MB-CART19.1.
EXPLORATORY OBJECTIVES:
I. To assess the change in cellular and cytokine tumor microenvironment following CAR T cell infusions.
II. To assess the T cell phenotype of pre-infusion and persisting CAR T cells in the blood and CSF.
III. To assess development of B cell aplasia.
IV. To assess cerebrospinal fluid (CSF), radiographic, and electroencephalography (EEG) changes in the first 2 weeks following CAR T cell infusion.
OUTLINE: This is a dose-escalation study of MB-CART19.1.
Patients undergo leukapheresis over 2-4 hours two to three weeks prior to administration of MB-CART19.1. Patients then undergo conditioning chemotherapy consisting of fludarabine intravenously (IV) over 30-45 minutes and cyclophosphamide IV over 30-60 minutes on days -5, -4, and -3 in the absence of disease progression or unacceptable toxicity. Patients then receive MB-CART19 IV over 5-15 minutes on day 0. Patients also undergo positron emission tomography (PET) and echocardiogram or multi-gated acquisition (MUGA) scan during screening, as well as magnetic resonance imaging (MRI) and blood sample collection throughout the study. Patients may also undergo bone marrow biopsy and aspiration as clinically indicated.
After completion of study treatment, patients are followed up at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24, at months every 3 months for 2 years, and then once a year for up to 15 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorIvan Kotchetkov