Status:
NOT_YET_RECRUITING
Personalized Vaccine for TNBC Immunotherapy
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Fundación Salud de los Andes
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
Due to their genetic instability, breast tumors that do not express receptors for Estrogens, Progestagens or amplify the Her2 / neu oncogene \[called triple-negative breast cancer (TNBC)\] and other t...
Eligibility Criteria
Inclusion
- 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.
- Have a functional status (Karnofsky Scale) greater than 70%.
- Weight equal to or greater than 50 kilograms.
- The chemical synthesis of at least one tumor NEOANTIGEN expressed exclusively by your tumor was successful.
- The apheresis procedure successfully allowed the obtaining of sufficient white blood cells to obtain leukocytes necessary for functional tests and for the derivation of dendritic cells.
Exclusion
- Active and/or uncontrolled cardiovascular disease.
- You are pregnant or breastfeeding.
- Has associated medical comorbidities such as diabetes or kidney failure, or coagulation disorders.
- You have been hospitalized in the last month.
- Has another active primary tumor except for skin tumors.
- Patients who are linked to another clinical study.
- Patients with a history of infectious diseases such as HIV, Hepatitis, tuberculosis.
- Consumption of immunosuppressive medications such as corticosteroids (except topical).
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06195618
Start Date
August 1 2025
End Date
June 1 2028
Last Update
June 25 2025
Active Locations (1)
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1
Facultad de Medicina - Universidad Nacional de Colombia
Bogotá, Bogota D.C., Colombia, 111321