Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients (InHeVac01)

University Hospital Tuebingen

Status

Conditions: Cancer

Treatments: Biological: Personalized multi-peptide vaccine

Study type: Expanded Access

Funder types: Other

Identifiers

NCT05014607

InHeVac01

Details and patient eligibility

About

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.

Full description

Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.

Sex: All

Volunteers: No Healthy Volunteers

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