NCT07374029

Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML

A Phase 1, First in Human Study of Adoptive T Cell Therapy With T Cells Stimulated by Dendritic Cell (DC)/Tumor Fusions in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (AML)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: David Avigan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to test if the combination of a new T cell therapy (dendritic cell (DC) / acute myeloid leukemia (AML) primed T cells), vaccine (DC/AML fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and effective for treatment of acute myeloid leukemia (AML). The names of the study drugs involved in this study are: * DC/AML fusion vaccine (immune cell vaccine) * Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone) * DC/AML Primed T cells (immune cells) * Decitabine (a type of chemotherapy drug) * Venetoclax (a type of antineoplastic agent)

Detailed description

The study is a dose escalation phase I clinical trial to evaluate the feasibility, safety, clinical and immune effects of adoptive T cell therapy with DC/AML Primed T cells in participants with acute myeloid leukemia (AML) treated with decitabine and venetoclax. The U.S. Food and Drug Administration (FDA) has not approved DC/AML Vaxprimed T cells as a treatment for any disease. This is the first time that DC/AML Primed T cells will be given to humans. The U.S. Food and Drug Administration (FDA) has not approved DC/AML fusion vaccine as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved GM-CSF, decitabine and venetoclax as treatment options for acute myeloid leukemia (AML). It is expected that about 30 people will take part in this research study

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia, in Relapse

Interventions

Type	Name	Description
BIOLOGICAL	DC/AML Fusion Vaccine	Autologous fusion vaccine of dendritic cells and AML cells, via subcutaneous injection (under the skin) per standard of care.
BIOLOGICAL	T-Cell Therapy	Autologous adoptive T cells, via intravenous (into the vein) infusion, per protocol.
DRUG	Decitabine	A pyrimidine nucleoside analogue, via intravenous infusion, per standard of care.
DRUG	Venetoclax	A BCL-2 inhibitor, taken orally per standard of care.
DRUG	GM-CSF	A Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-10-01
• Completion: 2030-10-01
• First posted: 2026-01-28
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study