Clinical trial · Interventional
DNA Vaccination Against Neuroblastoma
Pilot Clinical Study of DNA Vaccination Against Neuroblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is pilot open-label study to evaluate the safety and immunogenicity of a DNA vaccine strategy in relapsed neuroblastoma patients following chemotherapy and HSC transplantation. The combined form of the vaccine includes an intramuscular injection of the DNA-polyethylenimine conjugate and oral administration using the attenuated Salmonella enterica as DNA vaccine carriers. Objectives of the study: 1. To assess safety and document local and systemic toxicity to combined DNA vaccine 2. To determine immunogenicity of the vaccine 3. To evaluate clinical response to vaccination. Control of minimal residual disease in bone marrow and duration of remission.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA vaccine | Biological | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Salmonella oral vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All subjects
- description
- All subjects will receive the vaccine and be followed per the schedule of procedures.
- interventionNames
- Biological: DNA vaccine
- Biological: Salmonella oral vaccine
- Drug: Lenalidomide
Primary outcomes (4)
- measure
- Adverse events experienced by subjects
- timeFrame
- for 3 months from the first vaccination
- description
- To assess the safety of the DNA-PEI and Salmonella vaccines
- measure
- Immune response to the vaccine
- timeFrame
- In check point after 2nd course (9 week after first vaccine)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. The diagnosis of neuroblastoma recurrence with morphological / cytological confirmation; 2. The presence of tumor tissue for biopsy; 3. The absence of progression or a large tumor mass (bulky disease); 4. The physical status on the scale of ECOG 0 - 2. 5. Life expectancy of at least 12 months 6. Indicators of cellular immunity of the blood: lymphocytes - at least 1 \* 10\^9; 7. Availability of written informed consent of the patient and his parents (legal representatives) to participate in this protocol. 8. Compliance of parents (legal representatives) and the patient himself with participation in the study protocol. Exclusion Criteria: A. Based on the anamnesis: 1. The presence of any primary immunodeficiency; 2. The presence of a primary multiple malignant tumor; 3. The presence of autoimmune diseases in history (except thyroiditis); 4. Polyalgia; 5. Severe diseases, including those with severe symptoms, untreated inflammatory and infectious processes, due to which the patient cannot receive treatment in accordance with the study protocol. 6. Socioeconomic or geographical circumstances that cannot guarantee proper compliance with the requirements of the protocol for treatment and further observation. B. based on survey data: 1. The absence of expression in the tumor tissue of two or more antigens used in the protocol; 2. The level of peripheral blood leukocytes \<1.5 × 10\^9 /L, platelet \<50.0 × 10\^9 /L, Hemoglobin less than 80 g / L; 3. Positive tests for human immunodeficiency virus (HIV), hepatitis B or C. 4. Severe impaired liver function - the levels of AST / SGOT or ALT / SGPT exceed the upper limit of normal 5 times or more.
References
Publications (0)
Data not yet available