Last updated on June 2019

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Subjects With Aggressive B-Cell Non-Hodgkin Lymphoma

Brief description of study

Phase 2 single-arm, multi-cohort study to determine the efficacy and safety of JCAR017 (autologous T cells expressing anti-CD19 chimeric antigen receptor) in adult subjects with aggressive B-NHL (diffuse large B-cell lymphoma (DLBCL) NOS [de novo or transformed follicular lymphoma (tFL)], double/triple-hit lymphoma [DHL/THL], follicular lymphoma Grade 3B [FL3B], primary central nervous system lymphoma [PCNSL] and Richter's transformation).

Detailed Study Description

This is a single-arm, multi-cohort, multi-center, Phase 2 study to determine the efficacy and safety of JCAR017 in adult subjects with aggressive B-cell NHL. The study will enroll subjects in Europe and Japan with DLBCL NOS (de novo or tFL), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL), FL3B, PCNSL and Richter's transformation. Subjects with secondary central nervous system (CNS) involvement are allowed.

Once enrolled subjects will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, subjects will receive LD followed by infusion of JCAR017. JCAR017 will be administered at a dose of 1 x 10^8 JCAR017-positive transfected viable T cells by intravenous infusion.

Subjects will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life. Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.

Clinical Study Identifier: NCT03484702

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