Actively Recruiting
A Phase 1 Study of Adoptive T Cell Therapy Using DC/AML Fusion Vaccine with Decitabine and Venetoclax in Acute Myeloid Leukemia
Led by David Avigan · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for people with acute myeloid leukemia (AML), including those with AML in relapse. This phase 1 clinical trial aims to test the safety, feasibility, and immune effects of a combination therapy using adoptive T cell therapy with dendritic cell (DC)/AML primed T cells, a DC/AML fusion vaccine, and standard drugs decitabine and venetoclax. This is the first time DC/AML primed T cells and DC/AML fusion vaccine are being given to humans, while decitabine, venetoclax, and GM-CSF are approved treatments for AML. Participants receive treatment in multiple cycles. Initial cycles (1-2) involve decitabine given daily for 5 days and venetoclax daily for 21 days. After bone marrow biopsy and leukapheresis, dose escalation of T cells occurs in cycles 5-7 with continued decitabine and venetoclax, plus infusion of DC/AML primed T cells, DC/AML fusion vaccine, and GM-CSF on specific days. The study uses a dose escalation method to find the maximum tolerated dose of T cells. Follow-up visits happen monthly for 6 months, then every 3 months for 2 years, and yearly for 3 more years. During the trial, participants undergo blood tests, bone marrow biopsy, and leukapheresis to collect immune cells. Researchers closely monitor for treatment side effects including toxicity, infections, and immune reactions over several years. They measure outcomes such as successful manufacture and administration of vaccine-educated T cells, maximum tolerated dose, toxicity rates, relapse-free survival, minimal residual disease conversion, and overall survival. Participation may last years due to long-term follow-up for safety and effectiveness.
CONDITIONS
Brief Title
Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (AML) at initial diagnosis or first relapse planned for decitabine and venetoclax therapy
- ECOG performance status of 2 or less
- Normal organ and marrow function with bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 3 times upper limit, creatinine ≤ 2.0 mg/dL
- Agreement to use adequate contraception if of child-bearing potential or male participant
- Ability to understand and sign informed consent
- Achieved response of partial remission or better to decitabine and venetoclax before leukapheresis
- Resolution of grade III-IV toxicity from prior therapy except grade 3 anemia
- Laboratory values before leukapheresis: ANC ≥ 1,000/µL, platelets ≥ 50,000/µL, bilirubin ≤ 2.0 mg/dL, creatinine ≤ 2.0 mg/dL, AST/ALT ≤ 3 times upper limit
- Completed 4 cycles of decitabine and venetoclax without disease progression before receiving T cell therapy
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Eligible for intensive induction therapy at initial diagnosis
- Active systemic autoimmune disease requiring ongoing systemic therapy (except stable hypothyroidism)
- Prior allogeneic transplant
- Active HIV, untreated hepatitis C, or active hepatitis B infection
- Significant cardiac disease including symptomatic heart failure, unstable angina, or serious arrhythmias
- Pregnant or breastfeeding women
- Serious intercurrent illness such as infection requiring IV antibiotics prior to leukapheresis
- Patients choosing allogeneic transplant at remission time prior to leukapheresis
- Recent use of immunosuppressive medications within 14 days before first T cell infusion (with some exceptions)
- Female patients not using effective birth control or male patients not using effective contraception during treatment and for 90 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 cycles of 28 to 42 days each
Participants receive cycles of decitabine and venetoclax, followed by adoptive T cell therapy with DC/AML fusion vaccine, and GM-CSF according to the study protocol.
Multiple visits for baseline, cycles 1 to 7 including bone marrow biopsy and leukapheresis
Duration - Up to 5 years
Participants attend monthly visits for 6 months, then every 3 months for 2 years, and yearly for 3 years to monitor safety and long-term outcomes.
Monthly visits for 6 months, then every 3 months for 2 years, then yearly visits
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
D
David Avigan, MD
E
Emma Logan, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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