RecruitingPhase 1Phase 2NCT04729543

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

Adoptive Therapy With TCR Gene-engineered T Cells to Treat Patients With MAGE-C2-positive Melanoma and Head and Neck Cancer


Sponsor

Erasmus Medical Center

Enrollment

20 participants

Start Date

Oct 20, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of immune cell therapy called TCR T cells — immune cells engineered to recognize a protein called MAGE-C2 found on certain cancer cells — to treat patients with melanoma or head and neck cancer that no longer has effective treatment options. **You may be eligible if:** - You are 18 or older - You have metastatic or unresectable melanoma (skin, mucous membrane, or eye type) or metastatic head and neck squamous cell carcinoma - Your tumor tests positive for the MAGE-C2 protein - You carry a specific immune marker called HLA-A2*0201 - Your cancer has progressed after standard treatments - You have measurable disease and adequate blood counts and organ function - You are HIV-negative and hepatitis-negative **You may NOT be eligible if:** - You have active or untreated brain metastases, or cancer in the membranes around the brain - You have malignant fluid buildup around the lungs or in the abdomen - You are currently on chronic steroid therapy - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAdoptive therapy with autologous MC2 TCR T cells

Adoptive therapy with autologous MC2 TCR T cells combined with AZA/VP


Locations(1)

Erasmus Medical Center

Rotterdam, Netherlands

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NCT04729543


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