NCT04729543 MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 20 participants in total. It began in 2020-10-20 with a primary completion date of 2024-12-20.

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 weeks prior to the start of study treatment. For melanoma patients who are treated with BRAF- and MEK inhibitors, an interval of 2 weeks between discontinuation of BRAF- and MEK inhibition and start of study treatment is sufficient; 10. Patients with R/M HNSCC must have had objective evidence of disease progression and are ineligible for or unwilling to get platinum-based chemotherapy or for whom no standard treatment is available; 11. 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; 12. 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; Serology: * seronegative for HIV antibody; * seronegative for hepatitis B antigen, and hepatitis C antibody; * seronegative for lues. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation of this study: 1. presence of symptomatic brain metastasis. Note: subjects with symptomatic brain lesions who have been definitively treated with stereotactic radiation therapy, surgery, or gamma knife therapy are eligible; 2. Presence of active brain metastasis defined as new or progressive brain metastasis at the time of study entry. Note: subjects with treated or stable brain metastasis are eligible; 3. Presence of leptomeningeal metastasis; 4. Presence of malignant pleural effusion or ascites; 5. Systemic chronic steroid therapy (\>10 mg/day prednisone or equivalent) or any other immunosuppressive therapy within 7 days prior to leukapheresis or 72 hours prior to infusion of the MC2 TCR T cells. Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed; 6. Active, known or suspected autoimmune disease or a documented history of autoimmune disease. Note: subjects with vitiligo, controlled type 1 diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted; 7. Any active systemic infections, coagulation disorders or other active major medical illnesses, such as active autoimmune diseases requiring anti-TNF treatment; 8. History of myocardial infarction, cardial angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment; 9. AEs of previous treatment. Toxicities associated with prior systemic and non- systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or palliative radiotherapy (for non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less; 10. Women who are pregnant or breastfeeding. A negative pregnancy test before inclusion in the trial is required for all women of child bearing age; 11. Use of any live vaccines against infectious diseases within the last 3 months; 12. Active infection requiring systemic antibiotic therapy at start of study treatment; 13. Prior allogenic bone marrow or solid organ transplant; 14. History of known hypersensitivity to any of the investigational drugs used in this study; 15. Malignant disease, other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment, completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.

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