drugset / Trial / NCT02770820

Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia

NCT02770820

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects of laboratory-treated (central memory/naive) cluster of differentiation 8+ T cells (autologous Wilms tumor \[WT\]1-T cell receptor \[TCRc\]4 gene-transduced CD8-positive central memory T-cells \[TCM\]/naive T cells \[TN\] lymphocytes) and how well it works in treating patients with acute myeloid leukemia that is newly diagnosed or has come back. Genetically modified therapies, such as autologous WT1-TCRc4 gene-transduced CD8-positive TCM/TN lymphocytes, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called WT1, and safely given back to the patient. The "genetically modified" T-cells have genes added in the laboratory to allow them to recognize leukemia cells that express WT1 and kill them.

Timeline

Start
2017-11-06
Primary completion
2020-06-01
Completion
2020-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes Cell therapy Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous