- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014607
Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients (InHeVac01)
May 7, 2024 updated by: University Hospital Tuebingen
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.
Study Overview
Status
Available
Conditions
Intervention / Treatment
Detailed Description
Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Helmut R Salih, MD, CCU Translational Immunology, University Hospital Tübingen, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 23, 2021
First Submitted That Met QC Criteria
August 13, 2021
First Posted (Actual)
August 20, 2021
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InHeVac01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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