Clinical trial • Phase I • Oncology
CRISPR-TIL for Advanced or metastatic melanoma | Malignant melanoma stage III | Malignant melanoma stage IV
Phase I trial of CRISPR-TIL for Advanced or metastatic melanoma | Malignant melanoma stage III | Malignant melanoma stage IV. 10 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic melanoma | Malignant melanoma stage III | Malignant melanoma stage IV
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 19-12-2023
- First CTIS Authorization Date
- 10-04-2024
Trial design
Phase I trial across 1 site in Denmark.
- Target Sample Size
- 10
- Trial Duration For Participant
- 1461
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 19
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Herlev Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Inge Marie Svane
- Principal Investigator Email
- inge.marie.svane@regionh.dk
- Contact Person Name
- Inge Marie Svane
- Contact Person Email
- inge.marie.svane@regionh.dk
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Herlev Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- CRISPR-TIL
- Modality
- Cell therapy
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