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Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

This research is a Phase 1/2 study looking into a new cell therapy named gavo-cel (also known as TC-210) for advanced cancers that have a protein called mesothelin. These include types of mesothelioma, ovarian cancer, a bile duct cancer called cholangiocarcinoma, and non-small cell lung cancer. Gavo-cel is made from your own T-cells, which are a type of immune cell, specially trained to find and fight cancer cells with mesothelin. The study aims to figure out the best dose of gavo-cel and then see how well it shrinks tumours or stops them from growing, either by itself or when given alongside other cancer medicines. It's for adults who have already had some cancer treatment.

At a glance

What is this study about?

This study is a research project designed to explore a new type of treatment called gavo-cel. This treatment is a 'cell therapy,' which means it uses your own body's cells to fight cancer. Specifically, it uses your T-cells, which are special immune cells that usually help protect you from infections. For this treatment, some of your T-cells are taken from your blood, specially modified in a lab, and then given back to you. These modified T-cells are designed to recognise and attack cancer cells that have a specific protein on their surface called mesothelin.

The study is focusing on advanced cancers that have this mesothelin protein, including certain types of mesothelioma (a cancer affecting the lining of the lungs or abdomen), ovarian cancer, a bile duct cancer called cholangiocarcinoma, and non-small cell lung cancer. The main goals of this research are to first find the safest and most effective dose of gavo-cel, and then to see how well this treatment works in shrinking tumours or stopping their growth. Researchers will also look at whether gavo-cel works better when given with other approved cancer drugs that boost the immune system.

This is a 'Phase 1/2' study. Phase 1 trials are usually about safety and finding the right dose, while Phase 2 trials focus on how well the treatment works. By combining these phases, researchers can move more quickly to understand the potential of gavo-cel for people with these specific advanced cancers. It’s important to remember that this is a clinical trial, so it's a way of testing new treatments that aren't yet available as standard care.

Key takeaways

  • This is a study for a new cell therapy (gavo-cel) for specific advanced cancers.
  • It targets cancers that have a protein called mesothelin.
  • The study helps find the best dose and how well the treatment works.
  • It's for adults who have already received some previous cancer treatments.
  • You will be closely monitored throughout the study.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of certain advanced cancers: mesothelioma affecting the lung or abdomen, a specific type of ovarian cancer (serous ovarian adenocarcinoma), cholangiocarcinoma, or non-small cell lung cancer. Your cancer cells must also have a certain amount of the mesothelin protein detectable through a special test.

You would also need to have tried at least one standard cancer treatment before, unless you have cholangiocarcinoma and chose not to have initial treatments. However, you can't have had more than five previous lines of treatment. Your general health, including your heart and other organ functions, would need to be good enough to take part, and you'd need suitable veins for collecting your blood cells.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have a diagnosis of advanced mesothelioma, a specific ovarian cancer, cholangiocarcinoma, or non-small cell lung cancer?
  3. Has your doctor confirmed that your tumour has the mesothelin protein?
  4. Have you already had at least one, but no more than five, previous treatments for your cancer (with some exceptions)?
  5. Are you generally in good health, including your heart and other organs?
  6. Are you able to have a blood collection procedure similar to donating blood?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves reading and signing a consent form to make sure you fully understand what's involved. You would then undergo several tests to confirm your eligibility, including a detailed review of your cancer tissue. If you qualify, some of your blood would be collected in a process called 'leukapheresis' – similar to donating blood, but only white blood cells are collected – to create the gavo-cel treatment. You would then receive the gavo-cel treatment, potentially along with other approved cancer-fighting drugs like fludarabine, cyclophosphamide, Nivolumab, or Ipilimumab, as decided by the study doctors.

After treatment, you would have regular check-ups, assessments (like scans and blood tests) to see how you're responding to the treatment and to monitor for any side effects. The study involves multiple visits to the clinic, and the total duration of your participation, including follow-up, will be clearly explained to you by the study team. You'll be closely monitored throughout the study.

Potential risks and benefits

Participating in this study might offer a potential benefit of accessing an experimental treatment that could help control your cancer, especially if standard treatments haven't worked well for you. However, as with any new treatment, there are potential risks, and gavo-cel could cause side effects that are currently unknown or not fully understood. The procedures involved, like blood collection and infusions, also carry their own risks. All potential risks and side effects will be fully explained to you before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (11)

  • University of California, San Francisco
    Verified postcode
    San Francisco, United States
  • University of Miami Sylvester Cancer Center
    Verified postcode
    Miami, United States
  • University of Chicago Medical Center
    Verified postcode
    Chicago, United States
  • National Cancer Institute
    Verified postcode
    Bethesda, United States
  • Columbia University Medical Center
    Verified postcode
    New York, United States
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States
  • Duke University
    Verified postcode
    Durham, United States
  • University of Pennsylvania
    Verified postcode
    Philadelphia, United States
  • SCRI Oncology Partners
    Verified postcode
    Nashville, United States
  • University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Princess Margaret Cancer Centre
    Verified postcode
    Toronto, Canada

Common questions

What is gavo-cel?

Gavo-cel is a new type of cell therapy that uses your own specially trained immune cells to fight cancers that have a specific protein called mesothelin.

Which cancers is this study for?

The study is for advanced types of mesothelioma, a specific ovarian cancer, cholangiocarcinoma (bile duct cancer), and non-small cell lung cancer, provided they have the mesothelin protein.

Do I need to have had treatment before?

Yes, generally you must have had at least one previous standard treatment for your cancer, but no more than five. There's an exception for some cholangiocarcinoma patients.

What's the goal of this study?

The study aims to find the best dose of gavo-cel and see how well it works to shrink or control cancer, both alone and with other immune-boosting drugs.

Is gavo-cel a standard treatment?

No, gavo-cel is an experimental treatment being tested in a clinical trial. It's not yet a standard cancer treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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