maligne melanoma skin cancer uveal melanoma
Conditions
Interventions
Eligible patients will undergo leukapheresis to isolate autologous T cells.
These T cells will be transduced with a retroviral vector encoding the 1D3 HM
Cys TCR, and subsequently expanded during sh
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must be >= 18 years of age. Patients must have inoperable stage IIIc or stage IV cutaneous melanoma (AJCC), including ocular or mucosal melanoma, progressing after standard of care therapy Patients must be HLA-A2 positive. The primary tumor and/or metastasis have to be positive for MART-1 Patients must have a clinical performance status of ECOG 0 or 1. Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen. Patients must be able to understand and sign the Informed Consent document.
Exclusion criteria
Exclusion criteria: Life expectancy of less than three months. Requirement for systemic steroid therapy. Patients who have a history of CNS metastases. Patients with pleural effusion or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (CTCAE 4.0) of the TCR treatment Objective response rate according to RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression free survival (PFS) and median overall survival. Efficacy of induction of tumor specific T cell responses (as measured by the persistence of MART1 specific T cells in peripheral blood samples at several time points following adoptive transfer and in tumor biopsies when possible). | — |
Countries
Netherlands
Outcome results
None listed