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A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients with Aggressive B-cell NHL (TRANSCEND-PILOT-017006)
Protocol Number:
Phase II
Nina Wagner-Johnston
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this trial is to study the safety and anti-tumor activity of lisocabtagene maraleucel, also known as JCAR017 (a CAR T-Cell product), in patients with aggressive non-hodgkins lymphoma.
Patients must have relapsed from or be refractory to one line of prior treatment containing both an anthracycline and a CD20-targeted agent (for example, R-CHOP). Patients must have adequate organ function for CAR T cell treatment, but not be eligible for treatment with either high-dose chemotherapy or stem cell transplant.For 30 days after receiving JCAR017 patients must have daily caregiver support, accommodations within 60 minutes of the hospital, and have reliable transportation to the hospital.
Eligible patients will undergo leukapheresis (the collection of white blood cells from the blood). The collected cells will be used to generate JCAR017, a process that takes approximately 3-4 weeks to complete. Upon successful JCAR017 generation, patients will receive 3 days of lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide, followed by the administration of JCAR017.
Last Update
08/11/2020 05:02 AM