Breast Cancer Neoantigen Vaccination With Autologous Dendritic Cells

NCT04105582 | Completed Phase 1

• 1 other identifier: TEBICA002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Triple Negative Breast Cancer

Keywords

Dendritic cells; Neo-antigen; Personalized medicine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Adverse effects and Safety

  Number of participants with a treatment-related adverse event as associated with dendritic cells and neo-antigen inoculation assessed by CTCAE v4.0

  One year after innoculation

Secondary Outcomes (1)

• Neoantigen Immunogenicity

  6 months after last innoculation

Study Arms (1)

Neo-antigen pulsed Dendritic cell

EXPERIMENTAL

Autologous dendritic cells pulsed with tumor-specific neo-antigen (synthetic peptide)

Biological: Neo-antigen pulsed Dendritic cell

Interventions

Neo-antigen pulsed Dendritic cell BIOLOGICAL

Patients that have already finished their conventional treatment (chemotherapy and/or surgery) will be vaccinated with dendritic cells pulsed with synthetic peptide

Neo-antigen pulsed Dendritic cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• Fundación Salud de los Andes: collaborator

Study Sites (1)

Universidad Nacional de Colombia

Bogota, Cundinamarca, 111321, Colombia

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carlos A Parra-Lopez, MD PhD

  Full Professor School of Medicine. Microbiology Department.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)