NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

Patients will be treated with lymphodepletion chemotherapy (as recommended by the CAR-T cell manufacturer) and soon after will receive a one-time CD19-directed CAR-T cell infusion (as per product label). Study drug (NKTR-255 or placebo) will be administered intravenously approximately 14 days after CAR-T cell infusion and administered every 3 weeks for up to 7 cycles or 5 months (whichever is earlier) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed-up at 30 days, and then at 9,12,18, 24, and 36 months after CAR-T cell infusion. The Stage 1 (Phase II) portion of the study only enrolled to the dose optimization. Primary endpoint data will be available in the second half of 2024.