Clinical trial · Interventional
Breast Cancer Neoantigen Vaccination With Autologous Dendritic Cells
Phase I Clinical Study of Immunotherapy With Personalized Synthetic Vaccines in Patients With Triple Negative Breast Cancer
- 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)
In this project, the investigators propose the first clinical study in Colombia of vaccination of patients with triple-negative breast cancer (TNBC) using synthetic peptides that contain mutations of the tumor itself that will be presented to the immune system by autologous dendritic cells to assess immunogenicity and safety of this type of personalized vaccine. Achieving the specific objectives set out in this project will mean that the investigators can validate in Colombia the experimental design necessary to identify exclusive epitopes in the tumors of the participants in this study, and also that have been able to demonstrate the safety and immunogenicity of these vaccines.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo-antigen pulsed Dendritic cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neo-antigen pulsed Dendritic cell
- description
- Autologous dendritic cells pulsed with tumor-specific neo-antigen (synthetic peptide)
- interventionNames
- Biological: Neo-antigen pulsed Dendritic cell
Primary outcomes (1)
- measure
- Adverse effects and Safety
- timeFrame
- One year after innoculation
- description
- Number of participants with a treatment-related adverse event as associated with dendritic cells and neo-antigen inoculation assessed by CTCAE v4.0
Secondary outcomes (1)
- measure
- Neoantigen Immunogenicity
- timeFrame
- 6 months after last innoculation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Be a patient who is prescribed as a treatment for her cancer initiating neo-adjuvant chemotherapy with Doxorubicin / cyclophosphamide (A / C) administered prior to cycles with Taxanes and followed by surgery to remove the tumor. * Be between 18 and 75 years old. * That the patient agrees to participate in the Clinical Study prior to the start of chemotherapy. * Have free venous access. * Signature of informed consent. Exclusion Criteria: * Heart disease. * Diabetes * Renal impairment * Coagulation disorders * Have been hospitalized in the last month * Have another active tumor with the exception of skin tumors of the squamous-cell or basal-cell carcinoma.
References
Publications (0)
Data not yet available