OncoMatch/Clinical Trials/NCT04729543
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Is NCT04729543 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Adoptive therapy with autologous MC2 TCR T cells for melanoma.
Treatment: Adoptive therapy with autologous MC2 TCR T cells — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HLA-A A*0201
Patients must be HLA-A2*0201 positive
Required: MAGEC2 expression >5% tumor cells (>5% of tumor cells)
Primary tumor and/or metastasis (archival or fresh biopsy) is positive for MC2 (>5% of tumor cells) according to immunohistochemistry
Disease stage
Required: Stage IV
unresectable or metastatic cutaneous or mucosal melanoma; metastatic uveal melanoma; R/M HSNCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard systemic therapy — melanoma: unresectable/metastatic; uveal melanoma: metastatic; HNSCC: recurrent/metastatic
no standard treatment is available (anymore); progressing after standard of care therapy, if available; must have had objective evidence of disease progression while on or after standard systemic therapy
Cannot have received: allogenic bone marrow or solid organ transplant
Prior allogenic bone marrow or solid organ transplant
Lab requirements
Blood counts
absolute neutrophil count greater than 1.5x10^9/L; platelet count greater than 75x10^9/L; hemoglobin greater than 5 mmol/L or 8.0 in g/dl
Kidney function
serum creatinine < 1.5 ULN
Liver function
serum ALAT/ASAT less than 3 times the upper limit of normal (ULN), unless patients have liver metastasis (<5 times ULN); total bilirubin ≤ 20 micromol/L, except in patients with Gilbert's Syndrome who must have a total bilirubin ≤ 50 micromol/L
Patients must meet the following laboratory values at the screening visit in the absence of growth factors and/or transfusion support: Hematology: absolute neutrophil count greater than 1.5x10^9/L; platelet count greater than 75x10^9/L; hemoglobin greater than 5 mmol/L or 8.0 in g/dl; Chemistry: serum ALAT/ASAT less than 3 times the upper limit of normal (ULN), unless patients have liver metastasis (<5 times ULN); serum creatinine < 1.5 ULN; total bilirubin ≤ 20 micromol/L, except in patients with Gilbert's Syndrome who must have a total bilirubin ≤ 50 micromol/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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