drugset / Trial / NCT05664217

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

NCT05664217

Phase 2/3 Terminated 15 enrolled Nektar Therapeutics
RandomizedSequentialQuadruple-blindTreatment

Summary

This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Chimeric antigen (CAR)-T cell product consists of genetically engineered T-cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.

Timeline

Start
2022-12-23
Primary completion
2024-05-22
Completion
2024-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject NKTR-255 Protein / enzyme biologic 1.5 ug/kg
Subject NKTR-255 Protein / enzyme biologic 3 ug/kg
Subject NKTR-255 Protein / enzyme biologic 6 ug/kg