A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

Prior treatment

• Patients ineligible to receive CD19 CAR T-cell therapy

Other illness

• Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
• Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Age

• Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years

Other

• Primary CNS lymphoma
• Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)

• 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