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
Memorial Sloan Kettering Cancer Center
Summary
This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Men and women who are at least 18 years of age on the day of consenting to the study. * Histologically documented primary or secondary central nervous system lymphoma of DLBCL subtype * Relapsed/refractory primary or secondary CNSL patients. All relapsed//refractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of recurrences. * For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21 days of study c…
Interventions
- BiologicalMB-CART19.1 Cellular Therapy
MB-CART19.1 will be infused as a single infusion during an inpatient admission.
Locations (7)
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York