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Adoptive T Cell Therapy for Relapsed Acute Myeloid Leukemia

This study is testing a new combination treatment for Acute Myeloid Leukemia (AML), especially for patients whose AML has returned (relapsed). Researchers want to see if combining a T-cell therapy (DC/AML Primed T cells) and a vaccine (DC/AML fusion vaccine) with standard treatments, decitabine (a chemotherapy drug) and venetoclax (an anti-cancer drug), is safe and effective. You might be eligible if you have AML and your doctor plans to treat you with decitabine and venetoclax. This includes patients with specific gene changes (IDH or FLT-3 mutations). The study will look at how well the T-cell therapy can be made and given, its highest safe dose, and any side effects over time. About 30 people are expected to join.

Study design
This is a dose escalation phase I clinical trial, meaning it will test increasing doses of the T-cell therapy. Approximately 30 participants are planned for this study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will monitor for toxicity, including infections, for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07374029

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

Recruiting
PHASE1All AgesInterventionalTreatment
David Avigan
~30 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:DC/AML Fusion VaccineT-Cell TherapyDecitabineVenetoclaxGM-CSF

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Manufacture and Administration Rate of Vaccine-Educated T Cells
Measured over 28 weeks
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Acute Myeloid Leukemia, in Relapse

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • David Avigan, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

David Avigan, MD
[email protected]
617-667-9920
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have AML at initial diagnosis for which decitabine/venetoclax is planned as standard of care therapy. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine/venetoclax regimen is preferred per the treating physician.
Patients with AML in first relapse after cytotoxic and/or targeted therapy for which decitabine and venetoclax therapy is appropriate standard of care. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine/venetoclax regimen is preferred per the treating physician.
ECOG performance status ≤ 2 (Appendix A)
Participants must have normal organ and marrow function as defined below:
total bilirubin≤ 2.0 mg/dL
AST/ALT ≤ 3 × institutional upper limit of normal
creatinine ≤ 2.0 mg/dl
The effects of vaccine stimulated T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Patients must have obtained a response of PR or better to decitabine and venetoclax as defined in Section 11.
Resolution of all HMA/venetoclax related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia.
Laboratories:
ANC ≥ 1,000/µL
Platelets ≥ 50,000/uL
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
AST/ALT ≤ 3.0 x ULN
Patient completed 4 cycles of decitabine and venetoclax without evidence of disease recurrence or progression
Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia, at the time of initiation of cycle 5, 6, or 7 of decitabine/venetoclax therapy.
Laboratories:
ANC ≥ 1,000/µL
Platelets ≥ 50,000/uL
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
AST/ALT ≤ 3.0 x ULN
Generation of adequate yield of T cells to meet dosing requirement

Exclusion

Patients diagnosed with acute promyelocytic leukemia
Patients treated at initial diagnosis who are appropriate for intensive induction therapy.
Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are allowed.
Patients who have received a prior allogeneic transplant will be excluded.
Because of compromised cellular immunity, patients who have active human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients who, with their treating physician, choose to proceed with an allogeneic transplant at the time of remission will not be eligible for leukapheresis
Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are permitted.
Current or prior use of immunosuppressive medication within 14 days prior to first T cell infusion. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent
Known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting treatment, including dosing interruptions through 90 days after last dose of treatment. Refrain from egg cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.
Male subjects who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last dose of treatment. Refrain from sperm cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.

What this trial measures

  • Successful Manufacture and Administration Rate of Vaccine-Educated T Cells28 weeks

    Successful manufacture and administration rate is defined as the proportion of enrolled participants for whom autologous vaccine-educated T cells are successfully manufactured and administered per protocol.

  • Maximum Tolerated Dose (MTD) of Vaccine-Educated T Cells56 Days

    The MTD is defined as the highest dose level that one or fewer participants experiences a dose-limiting toxicity (DLT) or one dose level below the maximum administered dose level where two or more participants experience a DLT.

  • Toxicity Rate of Vaccine-Educated T Cells, Including CRS, Neurotoxicity, and Infections5 years

    Toxicity rate of vaccine-educated T cells is defined as the proportion of participants who experience at least one toxicity, including cytokine release syndrome, neurotoxicity, or infections, out of all participants who receive at least one T-cell infusion.