Dual Vaccine Trial in Myeloproliferative Neoplasms
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|ClinicalTrials.gov Identifier: NCT04051307|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Polycythemia Vera Essential Thrombocythemia||Drug: PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL Drug: Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dual Vaccine Trial in Myeloproliferative Neoplasms|
|Actual Study Start Date :||July 10, 2019|
|Estimated Primary Completion Date :||July 10, 2022|
|Estimated Study Completion Date :||July 10, 2022|
PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL Dose: 100 µg PD-L1 long1 dissolved in DMSO/water - Total volume: 0,5 ml.
ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL Dose: 200 µg ARGLong2 dissolved in DMSO/water - Total volume: 0,5 ml.
Both vaccines are given at a treatment. Adjuvant Montanide ISA 51 0,5ml is mixed with the peptides before treatment To be administered every second week - a total of twelve times, with a possibility of additional six treatments.
Drug: PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL
Other Name: PD-L1Long
Drug: Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL
Other Name: ARGLong2
- Immune response [ Time Frame: 1 year ]T-cell cytokine release towards target antigens
- Adverse events evaluated by CTCAE v. 5.0 [ Time Frame: 1 year ]Adverse events are graded 1-5 according to the criteria
- Clinical response [ Time Frame: 10 year ]Vaccinations will induce clinical response in 2 patients, either partial response or better, according response criteria for PV and ET or clinical response as a reduction of mutated allelic burden - 10% from baseline at any time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051307
|Contact: Jacob H Grauslund, MDfirstname.lastname@example.org|
|Herlev, Capital Region, Denmark, 2730|
|Contact: Jacob H Grauslund, MD|
|National Center for Cancer Immune Therapy (CCIT-DK)||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Jacob H Grauslund, MD +4538688961 email@example.com|
|Principal Investigator:||Jacob H Grauslund, MD||CENTER FOR CANCER IMMUNE THERAPY, CCIT-DK|