Clinical trial • Phase I • Other
Dendritic cells; frameshift-derived neopeptides for Lynch syndrome
Phase I trial of Dendritic cells; frameshift-derived neopeptides for Lynch syndrome. 20 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Lynch syndrome
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 13-06-2025
Trial design
Phase I trial across 1 site in Spain.
- Target Sample Size
- 20
- Trial Duration For Participant
- 1065
Eligibility
Recruits 20 Vulnerable population not selected; consent/assent handling not specified..
- Vulnerable Population
- Vulnerable population not selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Spain
- Earliest CTIS Part Ii Submission Date
- 18-02-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 115
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Gastroenterology
- Principal Investigator Name
- Francesc Balaguer
- Principal Investigator Email
- fprunes@clinic.cat
- Contact Person Name
- Francesc Balaguer
- Contact Person Email
- fprunes@clinic.cat
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
- Dendritic cells loaded with frameshift derived neopeptides
- Active Substance
- Dendritic cells; frameshift-derived neopeptides
- Modality
- Cell therapy|Peptide/protein/enzyme
- First In Human
- Yes
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