glioblastoma
Conditions
Brief summary
Phase 1 : Safety. Safety AEs will be evaluated and graded according to CTCAE v5.0 a) clinically at D0, W2, W4, W6, M2, M3, M4, M5, M7, M9, M11 and M12 ; b) with blood samples at D0, W2, W4, W6, M2, M3, M5, M7, M9, M11 and M12 ; c) with cerebral MRI at baseline, M2, M3 and every 2 months thereafter. Phase 2a : immune efficacy: anti-TERT specific T cell responses in peripheral blood using IFN-gamma ELISPOT at 2 months post first immunizations.
Detailed description
Evolution over time of anti-PTPRZ1 and anti-TERT immune T cell responses triggered by the vaccination protocol in peripheral blood using IFN-gamma ELISPOT before and during treatment (W2 for phase 1 only, W4, M2, M3, M5, M7, M9 and M12), Short and long-time safety, assessed clinically at D0, W2, W4, W6, M2, M3, M4, M5, M7, M9, M11 and M12 and with blood samples at D0, W2, W4, W6, M2, M3, M5, M7, M9, M11 and M12, Progression free survival with cerebral MRI at baseline, M2, M3 and every 2 months thereafter, Overall survival, Quality of life by EORTC QLQ30 and BN20 questionnaires at baseline and at 5 months
Interventions
DRUGPeptide A52 associated to melanin
DRUGLitenimod solution
DRUGPeptide A49 associated to melanin
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 : Safety. Safety AEs will be evaluated and graded according to CTCAE v5.0 a) clinically at D0, W2, W4, W6, M2, M3, M4, M5, M7, M9, M11 and M12 ; b) with blood samples at D0, W2, W4, W6, M2, M3, M5, M7, M9, M11 and M12 ; c) with cerebral MRI at baseline, M2, M3 and every 2 months thereafter. Phase 2a : immune efficacy: anti-TERT specific T cell responses in peripheral blood using IFN-gamma ELISPOT at 2 months post first immunizations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evolution over time of anti-PTPRZ1 and anti-TERT immune T cell responses triggered by the vaccination protocol in peripheral blood using IFN-gamma ELISPOT before and during treatment (W2 for phase 1 only, W4, M2, M3, M5, M7, M9 and M12), Short and long-time safety, assessed clinically at D0, W2, W4, W6, M2, M3, M4, M5, M7, M9, M11 and M12 and with blood samples at D0, W2, W4, W6, M2, M3, M5, M7, M9, M11 and M12, Progression free survival with cerebral MRI at baseline, M2, M3 and every 2 months thereafter, Overall survival, Quality of life by EORTC QLQ30 and BN20 questionnaires at baseline and at 5 months | — |
Countries
France
Outcome results
None listed