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

NCT07374029 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-05

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • David Avigan

    lead OTHER

Principal Investigators

  • David Avigan, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-12
Primary Completion
2027-10-01
Completion
2030-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07374029 on ClinicalTrials.gov