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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
Patients will be treated with lymphodepletion chemotherapy (as recommended by the CAR‐Tcell manufacturer) and soon after will receive a one‐time CD19‐directed CAR‐T cellinfusion (as per product label). Study drug (NKTR‐255 or placebo) will be administeredintravenously approximately 14 days after CAR‐T cell infusion and administered every 3weeks for up to 7 cycles or 5 months (whichever is earlier) in the absence of diseaseprogression or unacceptable toxicity. After completion of study treatment, patients willbe followed‐up at 30 days, and then at 9,12,18, 24, and 36 months after CAR‐T cellinfusion.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.
Epistemonikos ID: 4b00e014156fbc61413c895fd37298fe13b14c21
First added on: May 14, 2024