Personalized Vaccine for TNBC Immunotherapy

Launched by UNIVERSIDAD NACIONAL DE COLOMBIA · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of treatment for women with triple-negative breast cancer (TNBC), which is a particularly aggressive form of breast cancer. The study aims to create a personalized vaccine that targets specific mutations found in each patient’s tumor. By using these unique mutations, the hope is to activate the body’s immune system to recognize and destroy cancer cells more effectively. The trial is still in its early stages and has not yet started recruiting participants.

To be eligible for this trial, participants must be women aged 18 to 75 who have been diagnosed with TNBC and have already undergone some form of treatment, such as chemotherapy or surgery. They should also be in good overall health and able to provide access to their blood for testing. If you decide to participate, you can expect to receive a personalized vaccine created from the specific characteristics of your tumor, along with close monitoring of your health throughout the study. This trial represents an exciting step toward developing more effective treatments for breast cancer, aiming to improve survival rates and quality of life for patients facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Be between 18 and 75 years of age.
• • 2. Histologically confirmed diagnosis of primary triple negative breast carcinoma (TNBC).
• • 3. 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.
• • 4. Have frank venous access.
• • 5. Have a functional status (Karnofsky Scale) greater than 70%.
• • 6. Weight equal to or greater than 50 kilograms.
• • 7. The chemical synthesis of at least one tumor NEOANTIGEN expressed exclusively by your tumor was successful.
• • 8. 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 Criteria:
• • 1. Active and/or uncontrolled cardiovascular disease.
• • 2. You are pregnant or breastfeeding.
• • 3. Has associated medical comorbidities such as diabetes or kidney failure, or coagulation disorders.
• • 4. You have been hospitalized in the last month.
• • 5. Has another active primary tumor except for skin tumors.
• • 6. Patients who are linked to another clinical study.
• • 7. Patients with a history of infectious diseases such as HIV, Hepatitis, tuberculosis.
• • 8. Consumption of immunosuppressive medications such as corticosteroids (except topical).