A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-cell lymphoma.

Key Inclusion Criteria

1. 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.

2. 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.

3. Participant achieved CR, or PR suitable for observation at the end of first line

therapy based on PET/CT evaluation

4. Foresight CLARITYâ„¢ IUO MRD test, powered by PhasED-Seqâ„¢, is positive.

5. Adult participants ≥18 years of age.

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function

8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or

grade ≤1.

Key Exclusion Criteria

1. 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.

2. Prior treatment with anti-CD19 targeted therapies.

3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD

testing is performed.

4. Active and clinically significant autoimmune disease.

5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment

(e.g., HIV).

6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis,

smoldering multiple myeloma) within 3 years prior to enrollment.