Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Prior treatment

• Ongoing non-hematologic toxicities due to prior therapy
• 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).

Other illness

• History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Recent systemic anti-cancer therapy or radiation
• History of allogeneic stem cell or solid organ transplantation
• History of autoimmune disease resulting in end organ injury or requiring recent therapy
  • Other protocol-defined criteria apply.

Other

• Active central nervous system involvement
• Ongoing or impending oncologic emergency
• Primary immunodeficiency

• 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.