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

Sponsor: University Hospital Tuebingen

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05014607

Patient View

This clinical trial offers personalized multi-peptide vaccines combined with TLR1/2 ligand XS15 for patients with advanced malignancies lacking standard treatment options. Eligible participants must have a low tumor burden, a life expectancy over six months, and an ECOG score ≤ 2. Vaccines are administered subcutaneously every six weeks, with two to five doses planned.

Patient Parameters

Program Overview

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 §13 Absatz 2b, AMG.

Eligibility Criteria

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

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