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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
David Avigan
Study ID
NCT07374029
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Feb 12, 2026
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adoptive T cell therapy with DC/AML fusion vaccine, decitabine, and venetoclax
    * Baseline visit * Cycles 1 - 2 (28-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Days 1 - 21: predetermined dose of Venetoclax 1x daily * Bone marrow biopsy and aspiration at end of Cycle 2 * Leukapheresis * Cycles 3 - 4 (28-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Days 1 - 21: predetermined dose of Venetoclax 1x daily
  • Experimental: Dose-Escalation
    A standard 3+3 dose escalation design will be used to find the maximum tolerated dose (MTD) of T cells. If less than 1 out of 3 or less than 2 out of 6 participants experience a dose-limiting toxicity (DLT) in a given cohort then escalation will proceed to the next dosing level. If 2 out of 6 participants experience a DLT then the prior dose level will be defined as the MTD. An additional 12 participants will be treated at the MTD. -Cycles 5 - 7 (42-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Day 15: predetermined dose of DC/AML Primed T cells 1x daily * Days 1 - 14: predetermined dose of Venetoclax 1x daily * Day 29: predetermined dose of DC/AML fusion vaccine 1x daily * Day 29: predetermined dose of GM-CSF 1x daily Follow up visits monthly for 6 months Longer term follow up every 3 months for 2 years then yearly for 3 years

Primary Outcome Measure

Successful Manufacture and Administration Rate of Vaccine-Educated T Cells [ Time Frame: 28 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
David Avigan, MD
[email protected]
617-667-9920
David Avigan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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