Study of MC2 TCR T Cell Therapy and Epigenetic Drug Treatment for Patients with Advanced Melanoma or Head and Neck Cancer

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What is this study about?

This clinical trial is focused on treating patients with advanced melanoma or head and neck squamous cell carcinoma (HNSCC). The study involves a treatment using a special type of immune cells called MC2 TCR T cells, which are engineered to target cancer cells. These cells are combined with an epigenetic drug treatment, which involves using drugs that can change the activity of genes without altering the DNA sequence. The purpose of the study is to evaluate the safety and effectiveness of this combination treatment.

Participants in the study will receive the treatment through intravenous administration, meaning it will be delivered directly into the bloodstream. The study is divided into two phases. In the first phase, the focus is on determining the safety and the best dose of the MC2 TCR T cells when used with the epigenetic drug. The second phase will assess how well the treatment works in shrinking or controlling the cancer. Throughout the study, doctors will monitor for any side effects and measure how the cancer responds to the treatment.

The trial aims to find out if this new approach can be a viable option for patients with these types of cancer, especially those who have not responded to standard treatments. By using the patient’s own immune cells, which are modified to better fight the cancer, the study hopes to offer a more personalized treatment option. The results will help determine if this therapy can be used more widely in the future for treating advanced melanoma and HNSCC.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and specific health conditions.

Eligibility criteria include being 18 years or older, having advanced melanoma or head and neck cancer, and meeting specific genetic markers.

2 informed consent

The informed consent document is reviewed and signed. This document explains the study, potential risks, and benefits.

Understanding and agreeing to the terms is necessary before proceeding.

3 treatment preparation

Preparation for treatment involves a series of tests and evaluations to ensure safety and readiness.

This may include blood tests, imaging studies, and other assessments.

4 treatment administration

The treatment involves the administration of Gamma-retroviral vector MP71 MC2 TCR16-3D9 through intravenous administration.

The treatment is combined with epigenetic drug treatment to enhance effectiveness.

5 monitoring and follow-up

Regular monitoring is conducted to assess the body’s response to the treatment. This includes checking for any adverse effects and measuring the treatment’s impact on the cancer.

Follow-up visits are scheduled to evaluate progress and make any necessary adjustments to the treatment plan.

6 completion and evaluation

Upon completion of the treatment phase, a final evaluation is conducted to assess overall outcomes.

This includes determining the effectiveness of the treatment and documenting any long-term effects.

Who Can Join the Study?

Must be at least 18 years old.
Have advanced melanoma or HNSCC (head and neck squamous cell carcinoma) that cannot be removed by surgery, has worsened after standard treatment, or has come back/spread.
Must be HLA-A2 positive (a specific protein type on cells).
The main tumor or any spread of the cancer must test positive for MAGE-C2 (a specific protein).
Must have a clinical performance status of ECOG 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Both men and women must agree to use a highly effective method of birth control during treatment and for four months after the treatment.
Must be able to understand and sign the consent form, which explains the study and its risks.

Who Cannot Join the Study?

Patients with any other type of cancer besides advanced melanoma or HNSCC (head and neck squamous cell carcinoma) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar treatments cannot participate.
Patients with uncontrolled medical conditions that could interfere with the study cannot participate.
Patients who have received another investigational drug within a certain period before the study cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who have had a major surgery within a certain period before the study cannot participate.
Patients with a history of certain heart conditions cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Elatywq Uwxvczxewvyt Mudhgsh Cefsvqd Rblxlkxbc (mujrrdl Mxe	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.10.2020

Trial locations

Investigated drugs:

MC2 TCR T cells are a type of treatment that involves using your own immune cells to fight cancer. In this trial, your T cells, which are a part of your immune system, are taken from your body and genetically modified in a lab to better recognize and attack cancer cells that have a specific marker called MAGE-C2. Once these T cells are engineered, they are put back into your body to help your immune system target and destroy cancer cells more effectively.

Epigenetic drug treatment refers to a type of medication that can change the way your genes work without altering the DNA sequence. These drugs can help make cancer cells more visible to your immune system or make them more susceptible to being attacked by the engineered T cells. In this trial, the epigenetic drugs are used in combination with the MC2 TCR T cells to enhance the overall effectiveness of the treatment against melanoma and head and neck cancer.

Investigated diseases:

Advanced Melanoma – Melanoma is a type of skin cancer that begins in melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. Advanced melanoma refers to stages where the cancer has spread beyond the original site to other parts of the body, such as lymph nodes or distant organs. As the disease progresses, it can invade deeper layers of the skin and metastasize, making it more challenging to manage. The progression often involves changes in the size, shape, or color of existing moles or the appearance of new pigmented or unusual-looking growths on the skin. Advanced stages may lead to symptoms like unexplained pain, fatigue, or weight loss due to the spread of cancer cells. The disease can affect various body systems depending on where it spreads, impacting overall health and function.

Head and Neck Squamous Cell Carcinoma (HNSCC) – Head and neck squamous cell carcinoma is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized lesion that can grow and invade surrounding tissues. As the disease progresses, it may spread to nearby lymph nodes and, in advanced stages, to distant parts of the body. Symptoms often include persistent sore throat, difficulty swallowing, changes in voice, or a lump in the neck. The progression of HNSCC can lead to significant functional impairments, depending on the tumor’s location and size. Early detection is crucial, as the disease can become more complex to manage as it advances.

Trial ID:

2024-516922-70-00

NCT ID:

NCT04729543

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of MC2 TCR T Cell Therapy and Epigenetic Drug Treatment for Patients with Advanced Melanoma or Head and Neck Cancer

What is this study about?

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