Clinical trial • Phase III • Oncology
Tumor-infiltrating lymphocytes (neoantigen-selected) for Advanced epithelial tumors | Immune checkpoint blockade-resistant solid tumors
Phase III trial of Tumor-infiltrating lymphocytes (neoantigen-selected) for Advanced epithelial tumors | Immune checkpoint blockade-resistant solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced epithelial tumors | Immune checkpoint blockade-resistant solid tumors
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 09-10-2024
- First CTIS Authorization Date
- 21-10-2024
Trial design
Phase III trial across 1 site in Spain.
- Target Sample Size
- 10
Eligibility
Recruits 10 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in source.
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 63
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Spain
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 476
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@vhio.net
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Vall D Hebron Institute Of Oncology
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Contract research organisations
- Name
- Vall D Hebron Institute Of Oncology
- Responsibilities
- CRO Head (public contact: smunoz@vhio.net)
Investigational products
- Investigational Product Name
- Next-generation neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) therapy (NEXTGEN-TIL-ACT)
- Active Substance
- Tumor-infiltrating lymphocytes (neoantigen-selected)
- Modality
- Cell therapy
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