Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Key Inclusion Criteria:

• LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
• Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
• Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
• Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
• Adult participants ≥18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, renal, hepatic, pulmonary, and cardiac function
• Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Key Exclusion Criteria:

• LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
• Prior treatment with anti-CD19 targeted therapies.
• Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
• Active and clinically significant autoimmune disease.
• Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
• History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.