OncoMatch/Clinical Trials/NCT04729543
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Is NCT04729543 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT04729543 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogenic bone marrow or solid organ transplant disqualifies patients from enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*0201 is a required biomarker for enrollment.
Does this trial require MAGEC2?
Yes, MAGEC2 expression >5% tumor cells is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify