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The CD19 chimeric antigen receptor (CAR) T-cell therapy, tisagenlecleucel, demonstrated efficacy and acceptable levels of safety in patients with primary CNS lymphoma (PCNSL). Due to concerns regarding potential immune cell associated neurotoxicity syndrome (ICANS), this highly refractory patient population has previously been excluded from studies of this nature. Below, we summarize the findings of Frigault, et al., as published in Blood.1
In total, 12 patients with a median age of 63 years who had relapsed or refractory PCNSL were enrolled in this study. To be eligible, each patient had to be aged ≥18 years with disease progression or relapse following systemic high-dose methotrexate-based therapy. Patients aged >60 years were eligible if they were intolerant to first line therapy due to Grade ≥3 kidney or liver injury. All patients were required to have a confirmed diagnosis of PCNSL with no evidence of systemic disease.
Patients underwent leukapheresis before receiving a dose of 0.6–6.0 × 108 tisagenlecleucel CAR T-cells in line with current FDA approval for the treatment of systemic large B-cell lymphoma. Bridging therapy was allowed if followed by a 2-week washout from lymphodepleting agents before cell collection.
Post treatment MRI and CSF assessments were carried out monthly for 6 months, and quarterly up to 24 months. Radiographic responses were assessed independently by the Tumour Imaging Metrics Core in collaboration with the neuro-oncology department at Massachusetts General Hospital.
The results of this phase I/II clinical trial point to the viability of tisagenlecleucel as a treatment option for relapsed or refractory patients with PCNSL. The high response rate and acceptable safety profile are encouraging signs. The data in this trial are preliminary and the authors note that additional studies may be required; however, they suggest that broadening access to tisagenlecleucel for patients with PCNSL may improve clinical outcomes in this highly refractory patient population.
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