Clinical trial • Phase I • Haematology
multi-peptide(s) and XS15 (TLR1/2 ligand) for Acute myeloid leukemia
Phase I trial of multi-peptide(s) and XS15 (TLR1/2 ligand) for Acute myeloid leukemia. None/Not specified-controlled. 20 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Acute myeloid leukemia
- Trial Stage
- Phase I
- Drug Modality
- Vaccine|Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 18-04-2024
Trial design
None/Not specified-controlled Phase I trial across 1 site in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 20
Eligibility
Recruits 20 Vulnerable population not selected; no specific consent/assent handling mentioned..
- Vulnerable Population
- Vulnerable population not selected; no specific consent/assent handling mentioned.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 23
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Germany
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 18-04-2024
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- KKE Translationale Immunologie
- Contact Person Name
- Helmut Salih
- Contact Person Email
- kketi@med.uni-tuebingen.de
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Tuebingen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Multi-peptide vaccination adjuvanted with the TLR1/2 ligand XS15
- Active Substance
- multi-peptide(s) and XS15 (TLR1/2 ligand)
- Modality
- Vaccine|Peptide/protein/enzyme|Small molecule
- Combination Treatment
- Yes
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