lisocabtagene maraleucel (jcar017) as second-line therapy (transcend-pilot-017006)

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Nonhodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Summary: this is a phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (jcar017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive b-cell non-hodgkin lymphoma (nhl) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.


Eligibility criteria:
inclusion criteria: * confirmation of relapsed or refractory aggressive b-cell non-hodgkin lymphoma of the following histology at relapse: diffuse large b-cell lymphoma (dlbcl), not otherwise specified (nos; de novo or transformed follicular lymphoma \[tfl\]), high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangements with dlbcl histology (double/triple hit lymphoma \[dhl/thl\]), and follicular lymphoma grade 3b per who 2016 classification * previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a cd20-targeted agent * subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for car t cell treatment. * positron emission tomography (pet)-positive disease * histological confirmation of diagnosis at last relapse. enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated. * ecog performance status of 0, or 1, or 2 * adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line) * subjects must agree to use appropriate contraception * subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy exclusion criteria: * subjects with central nervous system (cns)-only involvement by malignancy (note: subjects with secondary cns involvement are allowed on study) * history of another primary malignancy that has not been in remission for at least 2 years. * previous treatment with cd19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment * active hepatitis b or hepatitis c infection at the time of screening * history of or active human immunodeficiency virus (hiv) infection at the time of screening * uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration * history of any one of the following cardiovascular conditions within the past 6 months: class iii or iv heart failure as defined by the new york heart association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease * history or presence of clinically relevant cns pathology * pregnant or nursing women * subject does not meet protocol-specified washout periods for prior treatments * prior hematopoietic stem cell transplant * progressive vascular tumor invasion, thrombosis, or embolism * venous thrombosis or embolism not managed on stable regimen of anticoagulation * uncontrolled medical, psychological, familial, sociological, or geographical conditions

Keywords: jcar017 lisocabtagene maraleucel nhl chimeric antigen receptor car car t cell autologous t cell therapy immunotherapy cell therapy liso-cel