Clinical trial · Interventional
Vaccination With PD-L1 Peptide Against Multiple Myeloma
Vaccination With PD-L1 Peptide With Montanide Against Multiple Myeloma After High Dose Chemotherapy With Stem Cell Support. A Phase I First-in-human Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Title: Vaccination with PD-L1 peptide with Montanide against multiple myeloma after high dose chemotherapy with stem cell support. A phase I first-in-human study. Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune checkpoint molecule PD-L1 to investigate the potential of vaccination against PD-L1 as a possible anticancer target.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-L1 peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccination
- description
- Vaccine: PD-L1 peptide.
- interventionNames
- Biological: PD-L1 peptide vaccine
Primary outcomes (1)
- measure
- Incidence of toxicity
- timeFrame
- 12 months
- description
- CTCAE = Common Terminology Criteria for Adverse Events v. 4.0 will be used for registration of toxicity
Secondary outcomes (1)
- measure
- Evaluation of immunological responses
- timeFrame
- 12 months
- description
- Immunological assays will be used to identify immunological responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically verified multiple myeloma 2. Newly treated with HDT and no signs of relapse 3. Age ≥18 years 4. Performance status ≤ 2 (ECOG-scale) 5. Expected survival \> 3 months 6. Sufficiently regenerated bone marrow function, i.e. 1. Leucocytes ≥ 1,5 x 109 2. Granulocytes ≥ 1,0 x 109 3. Thrombocytes ≥ 20 x 109 7. Creatinine \< 2.5 upper normal limit, i.e. \< 300 μmol/l 8. Sufficient liver function, i.e. 1. ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l 2. Bilirubin \< 30 U/l 9. Women agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment. 10. For men: agreement to use contraceptive measures and agreement to refrain from donating sperm. Exclusion Criteria: 1. Non-secretory myeloma 2. Other malignancies in the medical history excluding squamous cell carcinoma of the skin and patients cured for another malignant disease with no sign of relapse three years after ended treatment. 3. Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus. 4. Acute or chronic viral infection e.g. HIV, hepatitis or tuberculosis 5. Serious known allergies or earlier anaphylactic reactions. 6. Known sensibility towards Montanide ISA-51 7. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. 8. Pregnant and breastfeeding women. 9. Fertile women not using secure contraception with a failure rate less than \< 1% 10. Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment 11. Psychiatric disorders that per investigator judgment could influence compliance. 12. Treatment with other experimental drugs 13. Treatment with other anti-cancer drugs - except bisphosphonates and denosumab 14. Patients with active uncontrolled hypercalcemia 15. Patients who have received chemotherapy, immune therapy, radiation therapy within the last 28 days.
References
Publications (1)
- DERIVEDJorgensen NG, Klausen U, Grauslund JH, Helleberg C, Aagaard TG, Do TH, Ahmad SM, Olsen LR, Klausen TW, Breinholt MF, Hansen M, Martinenaite E, Met O, Svane IM, Knudsen LM, Andersen MH. Peptide Vaccination Against PD-L1 With IO103 a Novel Immune Modulatory Vaccine in Multiple Myeloma: A Phase I First-in-Human Trial. Front Immunol. 2020 Nov 9;11:595035. doi: 10.3389/fimmu.2020.595035. eCollection 2020. PMID 33240282