Immunotherapy using DC cells for treating Acute Myeloid Leukemia

Safety and Feasibility Study of Dendritic Cell (DC) Vaccination Expressing WT1/hTERT/Survivin in AML Patients With Minimal Residual Disease (MRD)

This study is testing a new vaccine made from special immune cells to see if it can help adults with acute myeloid leukemia who still have some cancer left after treatment stay cancer-free longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, cyclophosphamide
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05000801 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and efficacy of a novel dendritic cell (DC) vaccination loaded with tri-antigens (WT1, hTERT, and survivin) in patients with acute myeloid leukemia (AML) who have minimal residual disease after standard chemotherapy. The study will involve 20 adult patients aged 18 to 70 who have achieved morphological remission but still exhibit signs of minimal residual disease. Participants will receive a conditioning regimen followed by six infusions of the DC vaccine to assess its potential to prevent relapse and improve survival rates. The trial is being conducted at the 307 Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with acute myeloid leukemia who have achieved complete remission but have minimal residual disease.

Not a fit: Patients who are not eligible for this study include those who have already undergone stem cell transplantation or do not meet the specific molecular criteria for minimal residual disease.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of relapse and improve survival rates for patients with acute myeloid leukemia.

How similar studies have performed: While this approach is innovative, similar immunotherapy strategies have shown promise in other studies, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
* Patients completed induction and consolidation chemotherapy and have achieved complete remission (CR) by bone marrow biopsy criteria but with persistent MRD (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) and are not eligible for stem cell transplant
* Patients have MRD molecular relapse (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after achieved CR following induction and consolidation chemotherapy.
* Patients with molecular relapse (define by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after allogeneic stem cell transplant
* Leukemic cells express at least one of the following antigens: WT1, hTERT or survivin detected by qRT-PCR and/or flow cytometry or immunohistochemistry
* Karnofsky PS ≥60% or ECOG PS≤2.
* Patients must have organ and marrow function as defined below:

  * leukocytes \>=3,000/mcL
  * absolute neutrophil count \>=1,500/mcL
  * platelets \>=100,000/mcL
  * hemoglobin \>=9.0 g/dL
  * total bilirubin within normal institutional limits except in patients with Gilberts Syndrome who must have a total bilirubin \< 3.0 mg/dL
  * AST(SGOT)/ALT(SGPT) Serum ALT/AST \< 2.5X ULN
  * creatinine clearance Calculated creatinine clearance (CrCl) \>=50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
  * Adequate cardiac function: LVEF ≥50% by MUGA
* Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participation in any other interventional clinical trial during the study period.
* History or concomitant presence of any other malignancy, except for any other effectively treated malignancy that has been in remission for \>5 years or that is highly likely to be cured at the time of enrollment.
* Patients with a second invasive malignancy requiring treatment within the last 2 years are not eligible.
* Patients with any form of systemic immunodeficiency, including AIDS or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
* Active hepatitis B, C infection
* Patients on immunosuppressive drugs including corticosteroids.
* Patients with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
* Allergic to human albumin or IL-2. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
* Pregnant or breast-feeding.

Where this trial is running

Beijing, Beijing Municipality

• Department of hematology — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Liangding Hu, M.D. — the Fifth Medical Center the PLA General Hospital
• Study coordinator: Sun Yao, M.D.,Ph.D.

Conditions Acute Myeloid Leukemia