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

NCT02159495 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-09-16

No results posted yet for this study

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.

Conditions

  • Adult Acute Myeloid Leukemia in Remission
  • Acute Biphenotypic Leukemia
  • Early Relapse of Acute Myeloid Leukemia
  • Late Relapse of Acute Myeloid Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Secondary Acute Myeloid Leukemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Acute Myeloid Leukemia
  • Adult Acute Lymphoblastic Leukemia
  • Interleukin-3 Receptor Subunit Alpha Positive
  • Minimal Residual Disease
  • Refractory Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mustang Bio, Inc.

    collaborator INDUSTRY

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Lihua E. Budde · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2026-08-06
Completion
2026-08-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02159495 on ClinicalTrials.gov