RecruitingPhase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new immune cell treatment and an immune cell vaccine with the standard AML drugs decitabine and venetoclax. It will check whether this treatment can be given safely and whether it works. It is for people with acute myeloid leukemia (AML), a blood cancer, that is newly diagnosed or has come back for the first time.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed AML or AML that has come back for the first time, with decitabine and venetoclax planned as standard treatment.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Meet the study’s liver and kidney blood test limits.
  • Understand the study and agree in writing to take part.
  • Before immune cells are collected from your blood, the cancer must have at least partly responded to decitabine and venetoclax.
  • Before cell collection and study treatment, serious treatment side effects must have cleared, except for some low red blood cell counts. Infection-fighting cells and platelets, which help stop bleeding, must meet study limits.
  • Before the immune cell treatment and vaccine, finish 4 cycles of decitabine and venetoclax without the cancer returning or getting worse. Enough T cells must be available for treatment.
  • Follow birth control rules during treatment and for 90 days after the last dose. Do not donate eggs or sperm during vaccination or for at least 90 days after the last treatment dose.

Who can't join

  • Have acute promyelocytic leukemia, a specific type of AML, or be newly diagnosed and able to receive intensive starting chemotherapy.
  • Have had a stem cell transplant from a donor, or choose one when the cancer improves, before immune cell collection.
  • Have an active illness in which the immune system attacks the body and need ongoing whole-body treatment. Stable low thyroid hormone treated with replacement hormones and immune problems linked to AML are allowed.
  • Have HIV, untreated hepatitis C, or active hepatitis B.
  • Have serious active heart disease, such as heart failure with symptoms, unstable chest pain, or a serious uneven heartbeat.
  • Before immune cell collection, have a serious illness, such as an infection needing antibiotics through a vein.
  • Use medicines that weaken the immune system within 14 days before the first T cell treatment. Some local, inhaled, low-dose, or allergy-prevention steroids are allowed.
  • Be pregnant or breastfeeding, or not follow the required birth control rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria Prior to Tumor Collection * 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. Exclusion Criteria Prior to Tumor Collection * 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. Inclusion Criteria Prior to Leukapheresis * 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 Exclusion Criteria Prior to Leukapheresis * 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. Inclusion Criteria Prior to Treatment with DC/AML Primed T cells and DC/AML fusion vaccine * 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

Study sites (1)

MA