Acute Myeloid Leukemia, AdultPhase 1AML-VAC-XS15NCT06252584
Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients
A Phase 1 study testing Vaccines, Peptide in people with Acute Myeloid Leukemia, Adult, run by University Hospital Tuebingen.
Trial summary
The aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- Vaccines, Peptide
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2024to 2 Nov 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥18 years of age
- Existence of a written informed consent
- Documented diagnosis of AML according to WHO guidelines
- morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)
- positive MRD is permitted
- completion of previous intensive therapy (first vaccination 4-28 weeks after last application of chemotherapy) or
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- ongoing low intensity treatment with e.g. hypomethylating agents (HMA), venetoclax, etc.
- ongoing maintenance treatment with e.g. oral azacytidine or midostaurin is permitted.
- not eligible for allogeneic stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2
- Adequate organ function laboratory values.
- bilirubin ≤ 3 times upper limit range (exception isolated indirect hyperbilirubinemia (Morbus Gilbert-Meulengracht)).
- alanine aminotransferase (ALT) and aminotransferase (AST), ≤ 5 times upper limit range
- creatinine clearance GFR > 30 ml/min (CKD-EPI)
- platelets > 50.000/μl
- absolute CD3+ T cell count ≥ 200/μl
- negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion
- Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception (for more detailed information see chapter 5.7 Contraception, pregnancy, sperm donation and nursing). This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last vaccination).
- For FCBP two negative pregnancy tests (sensitivity of at least 25 mlU/mL) prior to first application of first vaccination, one at screening and the other prior (< 24 h) to first vaccination
- Postmenopausal or evidence of non-child-bearing status
Who cannot join
- Pregnant or breastfeeding.
- Unwilling or unable to follow the study schedule for any reason.
- Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted).
- Concurrent or previous treatment within 28 days in another interventional clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints.
- Major surgery within 28 days of dosing of study drug.
- Treatment with immunotherapy agents within 28 days of dosing of study drug.
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- Diagnosis of acute promyelocytic leukemia (APL)
- Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (< 10 mg/ day), in the past 1 year.
- Prior history of malignancies, other than AML/myelodysplastic syndrome (MDS), unless the subject has been free of the disease for
- ≥ 2 years. Exceptions include the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, histological finding of prostate cancer of TNM stage T1
- Prior stem cell allograft or organ transplantation
- Ongoing or active infection (including SARS-CoV-2)
- Have received any live vaccination within 28 days prior to the first dose of AML-VAC-XS15.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi-peptide Vaccination Adjuvanted With the TLR1/2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy
The aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.
Read the detailed description
Peptide vaccine: Multi-peptide vaccine cocktail comprising 9 different immunopeptidome-defined mutated and non-mutated AML/ leukemia stem and progenitor cell (LSC)-associated HLA class I and HLA class II peptides.
The vaccine cocktail is synthesized and formulated in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen (headed by Juliane Walz).
Treatment schedule:
The vaccine cocktail will be administered subcutaneously (s.c.) together with the (toll-like receptor )TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51 VG (1:1) as adjuvant.
Two vaccinations within a 6-week interval are planned, with the option of one additional booster in case of insufficient response after the first two vaccinations.
Peptide vaccination will take place in AML patients that have achieved a morphological complete remission (CR) or a complete remission with incomplete blood count recovery (CRi) with standard first line treatment. Minimal residual disease (MRD) positivity is permitted.
Vaccination will start 4-28 weeks after last application of intensive chemotherapy). Any maintenance treatment, e.g. with oral azacytidine or midostaurin, or ongoing low intensity therapy, e.g. with HMA, venetoclax etc. is permitted, can be applied throughout the vaccination and continued after study treatment according to the treating physician's decision.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- Vaccines, Peptide
- Keywords
- acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccines, PeptideDrug
Also called Multipeptide Vaccine AML-VAC-XS15
Multi-peptide vaccine cocktail comprising 9 different immunopeptidome-defined mutated and non-mutated AML/ leukemia stem and progenitor cell (LSC)-associated HLA class I and HLA class II peptides. The vaccine cocktail is synthesized and formulated in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen.
| Study group | Role | What they receive |
|---|---|---|
| Multipeptide Vaccination | Experimental | The vaccine cocktail will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 (50 μg) emulsified in Montanide ISA 51 VG (1:1) as adjuvant. Two vaccinations within a 6-week interval are planned, with the option of one additional booster in case of insufficient response after the first two vaccinations. Peptide vaccination will take place in AML patients that have achieved a morphological complete remission (CR) or a complete remission with incomplete blood count recovery (CRi) with standard first line treatment. MRD positivity is permitted. Vaccination will start 4-28 weeks after last application of intensive chemotherapy). Any maintenance treatment, e.g. with oral azacytidine or midostaurin, or ongoing low intensity therapy, e.g. with HMA, venetoclax etc. is permitted, can be applied throughout the vaccination and continued after study treatment according to the treating physician's decision. Receives: Drug: Vaccines, Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity
Blood will be taken before peptide vaccination and during vaccination phase and follow-ups at each visit
IFN-gamma ELISPOT Counts
Percentage of patients with induction of an AML-VAC-XS15-specific specific T-cell response until End of study visit (EOS) compared to baseline as determined by IFNγ ELISPOT.
Measured: Visit 1( Day 0); Visit 2 (Day 42); End of Treatment (Day 70); Follow-Up (Day160); Follow-Up 1(Day 188); Follow-Up 2 (Day 250)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 May 2024 (estimated)
- Primary completion2 May 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm Treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252584
- Sponsor's protocol ID
- AML-VAC-XS15-01
- Acronym
- AML-VAC-XS15
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-peptide Vaccination Adjuvanted With the TLR1/2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy
- ClinicalTrials.gov ID
- NCT06252584
- Acronym / sponsor ID
- AML-VAC-XS15 / AML-VAC-XS15-01
- Conditions
- Acute Myeloid Leukemia, Adult
- Keywords
- acute myeloid leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 9 Feb 2024 (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 Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.
Detailed description
Peptide vaccine: Multi-peptide vaccine cocktail comprising 9 different immunopeptidome-defined mutated and non-mutated AML/ leukemia stem and progenitor cell (LSC)-associated HLA class I and HLA class II peptides.
The vaccine cocktail is synthesized and formulated in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen (headed by Juliane Walz).
Treatment schedule:
The vaccine cocktail will be administered subcutaneously (s.c.) together with the (toll-like receptor )TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51 VG (1:1) as adjuvant.
Two vaccinations within a 6-week interval are planned, with the option of one additional booster in case of insufficient response after the first two vaccinations.
Peptide vaccination will take place in AML patients that have achieved a morphological complete remission (CR) or a complete remission with incomplete blood count recovery (CRi) with standard first line treatment. Minimal residual disease (MRD) positivity is permitted.
Vaccination will start 4-28 weeks after last application of intensive chemotherapy). Any maintenance treatment, e.g. with oral azacytidine or midostaurin, or ongoing low intensity therapy, e.g. with HMA, venetoclax etc. is permitted, can be applied throughout the vaccination and continued after study treatment according to the treating physician's decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm Treatment
| Arm | Type | Receives |
|---|---|---|
| Multipeptide Vaccination | Experimental | Drug: Vaccines, PeptideThe vaccine cocktail will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 (50 μg) emulsified in Montanide ISA 51 VG (1:1) as adjuvant. Two vaccinations within a 6-week interval are planned, with the option of one additional booster in case of insufficient response after the first two vaccinations. Peptide vaccination will take place in AML patients that have achieved a morphological complete remission (CR) or a complete remission with incomplete blood count recovery (CRi) with standard first line treatment. MRD positivity is permitted. Vaccination will start 4-28 weeks after last application of intensive chemotherapy). Any maintenance treatment, e.g. with oral azacytidine or midostaurin, or ongoing low intensity therapy, e.g. with HMA, venetoclax etc. is permitted, can be applied throughout the vaccination and continued after study treatment according to the treating physician's decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males or females aged ≥18 years of age
- Existence of a written informed consent
- Documented diagnosis of AML according to WHO guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2
- Adequate organ function laboratory values.
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding.
- Unwilling or unable to follow the study schedule for any reason.
- Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted).
- Concurrent or previous treatment within 28 days in another interventional clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints.
- Major surgery within 28 days of dosing of study drug.
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 |
|---|---|---|
| Vaccines, PeptideAlso: Multipeptide Vaccine AML-VAC-XS15Multi-peptide vaccine cocktail comprising 9 different immunopeptidome-defined mutated and non-mutated AML/ leukemia stem and progenitor cell (LSC)-associated HLA class I and HLA class II peptides. The vaccine cocktail is synthesized and formulated in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen. | Drug | Multipeptide Vaccination |
Primary outcome
immunogenicity
Time frame: Visit 1( Day 0); Visit 2 (Day 42); End of Treatment (Day 70); Follow-Up (Day160); Follow-Up 1(Day 188); Follow-Up 2 (Day 250)
Blood will be taken before peptide vaccination and during vaccination phase and follow-ups at each visit IFN-gamma ELISPOT Counts Percentage of patients with induction of an AML-VAC-XS15-specific specific T-cell response until End of study visit (EOS) compared to baseline as determined by IFNγ ELISPOT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccines, Peptide in people with Acute Myeloid Leukemia, Adult, 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 20 inclusion and 13 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 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Walz, Prof. Dr. (+49 7071 29 ext. 83275, kketi@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunogenicity (time frame: Visit 1( Day 0); Visit 2 (Day 42); End of Treatment (Day 70); Follow-Up (Day160); Follow-Up 1(Day 188); Follow-Up 2 (Day 250)). It is what the study was designed to measure, not a finding.
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 Feb 2024.