Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
NCT ID: NCT05014607
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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Personalized multi-peptide vaccine
Peptide vaccine: Personalized multi-peptide vaccine cocktails consisting of 200-300µg each of 1-10 tumor-associated peptides selected individually based on the patient-individual HLA allotypes and HLA ligandome analysis of tumor cells Peptides are synthesized in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen and will be formulated at the GMP-Center of the University Hospital Tübingen.
Peptides will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant.
Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned.
Treatment schedule:
Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned, depended on the induction of peptide-specific T-cell responses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Helmut R Salih, MD
Role: STUDY_CHAIR
CCU Translational Immunology, University Hospital Tübingen, Germany
Central Contacts
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Related Links
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Department CCU Translational Immunology
Other Identifiers
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InHeVac01
Identifier Type: -
Identifier Source: org_study_id
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