MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Trial Parameters
Brief Summary
Single-centre, first-in-man phase I/II trial to demonstrate safety and efficacy of MAGE-C2/HLA-A2 TCR T cells (MC2 TCR T cells) in advanced melanoma (MEL) and head-and-neck carcinoma (HNSCC).
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent; 2. Age ≥ 18 years; 3. One of the following three malignancies: * Previously treated for unresectable or metastatic cutaneous or mucosal melanoma for whom no standard treatment is available (anymore); * Metastatic uveal melanoma, progressing after standard of care therapy, if available; * R/M HSNCC for whom no standard treatment is available anymore; 4. Patients must be HLA-A2\*0201 positive; 5. Primary tumor and/or metastasis (archival or fresh biopsy) is positive for MC2 (\>5% of tumor cells) according to immunohistochemistry; 6. Measurable disease according to RECIST v1.1; 7. At least one lesion, suitable for sequential mandatory tumor biopsies; 8. ECOG performance status of 0 or 1. Life expectancy ≥ 12 weeks; 9. Patients with melanoma must have had objective evidence of disease progression while on or after standard systemic therapy. The last dose of prior therapy (e.g. anti- PD-1, chemotherapy) must have been received more than 4 wee