RecruitingPhase 1NCT07374029

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)


Sponsor

David Avigan

Enrollment

30 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called DC/AML Fusion Vaccine, a drug called Decitabine, and others for people with acute myeloid leukemia and acute myeloid leukemia, in relapse. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDC/AML Fusion Vaccine

Autologous fusion vaccine of dendritic cells and AML cells, via subcutaneous injection (under the skin) per standard of care.

BIOLOGICALT-Cell Therapy

Autologous adoptive T cells, via intravenous (into the vein) infusion, per protocol.

DRUGDecitabine

A pyrimidine nucleoside analogue, via intravenous infusion, per standard of care.

DRUGVenetoclax

A BCL-2 inhibitor, taken orally per standard of care.

DRUGGM-CSF

A Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT07374029


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