drugset / Trial / NCT03126864

Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

NCT03126864

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment). CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood cell). T-cells are genetically changed to help target leukemia cells. This is an investigational study. CD33-CAR-T is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 39 participants will be enrolled in this study. All will take part at MD Anderson.

Timeline

Start
2017-08-04
Primary completion
2019-10-10
Completion
2019-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CD33CART Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified 900 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous