Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
• Age 18 years or older
• Willing and able to provide written informed consent
• Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
• Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
• Relapsed or refractory disease.
• At least 1 measurable lesion (per Lugano classification)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
• Absolute neutrophil count (ANC) ≥ 1000/µL
• Platelet count ≥ 50,000/µL
• Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply.
• History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
• Active central nervous system involvement
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Ongoing or impending oncologic emergency
• Recent systemic anti-cancer therapy or radiation
• Ongoing non-hematologic toxicities due to prior therapy
• History of allogeneic stem cell or solid organ transplantation
• Autologous stem cell transplantation within 6 weeks
• History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
• Primary immunodeficiency
• History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.
DRUG: Rondecabtagene autoleucel (ronde-cel), DRUG: Fludarabine, DRUG: Cyclophosphamide
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma
CAR T-cell, Non-Hodgkin Lymphoma, CD19/20, CD19, CD20, NHL, Diffuse Large B-cell lymphoma, DLBCL, Transformed follicular lymphoma, TFL, Primary mediastinal B-cell lymphoma, PMBCL, Follicular lymphoma Grade 3B, Large cell follicular lymphoma, Aggressive B-cell NHL, Refractory Aggressive B-Cell Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cyclophosphamide, Fludarabine, Lymphoma, Follicular, Lymphoma, B-cell, Immunosuppressive Agents, Immunologic Factors, Disease Attributes, Immune System Diseases, Recurrence, PiNACLE