CancerInHeVac01NCT05014607
Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
A study testing Personalized multi-peptide vaccine in people with Cancer, run by University Hospital Tuebingen.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Personalized multi-peptide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.
- Conditions
- Cancer
- Being tested
- Personalized multi-peptide vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized multi-peptide vaccineBiological
Also called Adjuvants XS15 and Montanide ISA 51 VG
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helmut R Salih, MD, Study chair, CCU Translational Immunology, University Hospital Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014607
- Sponsor's protocol ID
- InHeVac01
- Acronym
- InHeVac01
- Status last verified
- May 2024
- First submitted
- 23 Jul 2021
- Last updated
- 9 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
- ClinicalTrials.gov ID
- NCT05014607
- Acronym / sponsor ID
- InHeVac01 / InHeVac01
- Conditions
- Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized multi-peptide vaccineAlso: Adjuvants XS15 and Montanide ISA 51 VGPeptide 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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Department CCU Translational ImmunologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut R Salih, MD study chair
CCU Translational Immunology, University Hospital Tübingen, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Personalized multi-peptide vaccine in people with Cancer, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliane S Walz, MD (07071/2968746, kketi@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.