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A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating their disease.
The primary objective is to estimate the efficacy of axicabtagene ciloleucel, as measured by objective response rate, in subjects with relapsed or refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). A key secondary endpoint will be progression-free survival (PFS). Additional secondary objectives will include additional safety and efficacy endpoints.
Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)