A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
• CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
• Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
‣ Diffuse large B-cell lymphoma (DLBCL)
⁃ Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
⁃ DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
⁃ High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)
⁃ Primary mediastinal large B-cell lymphoma (PMBCL)
⁃ Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B)
• Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
• Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hematological, renal, hepatic, pulmonary, and cardiac function