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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05014607
Acronym
InHeVac01
Enrollment
Unknown
Registered
2021-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

BIOLOGICALPersonalized 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.

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL

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

Contacts

Primary ContactJuliane S Walz, MD
kketi@med.uni-tuebingen.de07071/2968746
Backup ContactHelmut R Salih, MD
kketi@med.uni-tuebingen.de07071/2968746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026