The purpose of this study is to assess wether it is safe and feasible to treat patients with tumor infiltrating lymphocytes that have been silenced for PD-1, using CRISPR-Cas9.
Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).
Progressive disease after standard treatment with anti-PD-1 check-point inhibition or combination of aforementioned with anti-CTLA-4 check-point inhibition.
Age: 18 - 75 years at the time of signed Informed consent.
ECOG performance status of ≤1 (Appendix 2).
Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC.
Small molecules/TKI: Washout period 1 week before TR and LDC.
Immune therapy (monoclonal AB therapy, CPI, and biologics): 2 weeks before TR and LDC
Prior T-cell therapy, including gene therapy using an integrating vector.
Inge Marie Svane
Lead sponsor
Herlev Hospital
Sponsor institution