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ACTIVE NOT RECRUITING
NCT02159495
PHASE1

Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and the best dose of genetically modified T-cells after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement or has not responded to previous treatment. An immune cell is a type of blood cell that can recognize and kill abnormal cells in the body. The immune cell product will be made from patient or patient's donor (related or unrelated) blood cells. The immune cells are changed by inserting additional pieces of deoxyribonucleic acid (DNA) (genetic material) into the cell to make it recognize and kill cancer cells. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.

Official title: Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With CD123+ Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2015-12-15

Completion Date

2026-08-06

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

BIOLOGICAL

Allogeneic CD123CAR-CD28-CD3zeta-EGFRt-expressing T-lymphocytes

Given IV

DRUG

Fludarabine Phosphate

Given IV

Locations (1)

City of Hope Medical Center

Duarte, California, United States