Clinical trial • Phase I • Oncology
Tumor infiltrating lymphocytes (TILs) for Advanced or metastatic triple-negative breast cancer
Phase I trial of Tumor infiltrating lymphocytes (TILs) for Advanced or metastatic triple-negative breast cancer. 20 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic triple-negative breast cancer
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 13-06-2024
- First CTIS Authorization Date
- 20-06-2024
Trial design
Phase I trial across 4 sites in Spain.
- Target Sample Size
- 20
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 60
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 20
Spain
- Earliest CTIS Part Ii Submission Date
- 21-05-2024
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 517
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Eva Maria Ciruelos Gil
- Contact Person Email
- eva.ciruelos@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Marta Santisteban
- Contact Person Email
- msantisteb@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Aleix Prat
- Contact Person Email
- alprat@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Cristina Saura Manich
- Contact Person Email
- csaura@vhio.net
Sponsor
Primary sponsor
- Full Name
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Tumor infiltrating lymphocytes (TILs)
- Active Substance
- Tumor infiltrating lymphocytes (TILs)
- Modality
- Cell therapy
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