Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
- Conditions
- Cancer
- Registration Number
- NCT05014607
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
The aim of this project is to provide personalized multi-peptide vaccination in combination with the TLR1/2 ligand XS15 to individual patients with advanced solid and hematological malignancies without any approved treatment options.
- Detailed Description
Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented diagnosis of advanced malignant disease
- Advanced malignant disease without any available standard of care treatment option
- Low tumor cell burden
- Live expectancy > 6 month
- Ability to understand and voluntarily sign an informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
Exclusion Criteria
- Pregnant or lactating females.
- Treatment regimens inducing sever T cell deficiencies
- Treatment-related side effect > CTC grade 2 (CTCAE V5.0
- Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to vaccination
- Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method