A PHASE 2 MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA (INHL) - KTE-C19-105

Kite Pharma Inc.0 个研究点目标入组 158 人开始时间: 2023年7月26日最近更新: 2024年7月22日

适应症

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•18 Years and older., Individual has [follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP)., Individual has [measurable disease]., Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma., If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis., Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function, Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals)., Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).

•Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)., Small lymphocytic lymphoma., Histological Grade 3b FL., Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant., Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.).

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