advanced melanoma or HNSCC
Conditions
Brief summary
Phase I: AEs according to CTCAE 5.0, Phase I: Recommended Phase II dose, Phase I: Feasibility to deliver this sequence of treatmen, Phase II: Objective response rate according to RECIST v1 .1, Phase II: PFS, Phase II: OS
Detailed description
Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood., Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells, Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen, Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells
Interventions
DRUGGamma-retroviral vector MP71 MC2 TCR16-3D9
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: AEs according to CTCAE 5.0, Phase I: Recommended Phase II dose, Phase I: Feasibility to deliver this sequence of treatmen, Phase II: Objective response rate according to RECIST v1 .1, Phase II: PFS, Phase II: OS | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood., Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells, Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen, Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells | — |
Countries
Netherlands
Outcome results
None listed