A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma
This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).
• ≥ 18 years of age
• Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:
‣ Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
⁃ Primary mediastinal large B-cell lymphoma (PMBCL)
⁃ Transformed follicular lymphoma (tFL)
⁃ High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
⁃ High-grade B-cell lymphoma, NOS (HGBL, NOS)
⁃ Follicular lymphoma grade 3B (FL3B)
• Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
• At least one measurable lesion per the Lugano 2014 Classification
• Adequate organ and marrow function