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
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.
Arms & interventions
- BiologicalMB-CART19.1 Cellular Therapy
MB-CART19.1 will be infused as a single infusion during an inpatient admission.
Outcome measures
Primary
To identify the maximum tolerated dose (MTD)
The maximum tolerated dose (MTD) is defined as the highest dose level where a Dose limiting toxicity (DLT) occurs within at most one out of six patients treated. DLT is defined as any of the following adverse events (AEs) that occur within 28 days of the MB-CART19.1 infusion, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, TIAN grading65, or the ASTCT Consensus Grading guidelines for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity (ICANS).
Time frame: 1 year
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553