TEBICA003 TNBCESTUDIO CLÍNICO FASE I DE INMUNOTERAPIA CON VACUNAS SINTÉTICAS PERSONALIZADAS EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO
Peptide (neoantigen) pulsed autologous Dendritic cell
Breast Diseases+4
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study focuses on creating personalized synthetic vaccines as a treatment option for patients with triple-negative breast cancer (TNBC). TNBC is a challenging type of breast cancer that lacks certain receptors, making it difficult to treat with standard chemotherapy or radiation. This type of cancer is aggressive and has a high rate of mutations, which makes it more likely to resist typical treatments. The goal of this study is to explore how personalized vaccines, designed using the specific mutations found in a patient’s tumor, could potentially improve treatment outcomes. By harnessing the body's immune system to recognize and attack cancer cells, researchers hope to develop a more targeted therapy that could offer better survival rates and quality of life for patients. Participants in this study will undergo a process where the unique mutations in their tumors are identified through an analysis of the tumor's genetic material. Based on this information, a personalized vaccine is created, incorporating peptides that act as neo-antigens—newly created antigens that the immune system can target. This vaccine is then administered to the patient, aiming to stimulate their immune system to recognize and destroy the cancer cells. The study is in its early phase, primarily focusing on assessing the safety and immune response triggered by these vaccines. By determining how well these vaccines work in activating the immune system without causing harm, the study could pave the way for more personalized cancer treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Facultad de Medicina - Universidad Nacional de Colombia
Bogotá, ColombiaOpen Facultad de Medicina - Universidad Nacional de Colombia in Google Maps