Recruiting soon

TEBICA003 TNBCESTUDIO CLÍNICO FASE I DE INMUNOTERAPIA CON VACUNAS SINTÉTICAS PERSONALIZADAS EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO

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What is being tested

Peptide (neoantigen) pulsed autologous Dendritic cell

Biological
Who is being recruted

Breast Diseases+4

+ Breast Neoplasms

+ Neoplasms

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorUniversidad Nacional de Colombia
Study ContactCarlos A Parra-Lopez, MD PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleESTUDIO CLÍNICO FASE I DE INMUNOTERAPIA CON VACUNAS SINTÉTICAS PERSONALIZADAS EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO
NCT06195618
Principal SponsorUniversidad Nacional de Colombia
Study ContactCarlos A Parra-Lopez, MD PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesTriple Negative Breast Neoplasms

Criteria

8 inclusion criteria required to participate
Be between 18 and 75 years of age.

Histologically confirmed diagnosis of primary triple negative breast carcinoma (TNBC).

Patients who have already been treated, either with chemo/radiotherapy and/or surgery regimens, and in whom, according to previous preclinical studies, it was possible to clearly identify tumor NEOANTIGENS expressed by their tumor.

Have frank venous access.

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8 exclusion criteria prevent from participating
You have been hospitalized in the last month.

Active and/or uncontrolled cardiovascular disease.

You are pregnant or breastfeeding.

Has associated medical comorbidities such as diabetes or kidney failure, or coagulation disorders.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Triple-negative breast cancer patients with specific tumor mutation, with six doses of peptide-pulsed autologous dendritic cells after surgery

Study 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

Suspended

Facultad de Medicina - Universidad Nacional de Colombia

Bogotá, ColombiaOpen Facultad de Medicina - Universidad Nacional de Colombia in Google Maps
Recruiting soonOne Study Center