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NCT05014607 Clinical Trial

Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients

Cancer Clinical Trial

— InHeVac01  

Official title:
Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05014607
Other study ID # InHeVac01
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date July 2021
Source University Hospital Tuebingen
Contact Juliane S Walz, MD
Phone 07071/2968746
Email kketi@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Description:

Ethics: Patient treatment will be conducted according to ยง13 Absatz 2b, AMG.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Personalized multi-peptide vaccine
Peptide vaccine: Personalized multi-peptide vaccine cocktails consisting of 200-300µg each of 5-10 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen
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