All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors

This study is testing a new cell therapy called BOXR1030 for people with advanced solid tumours that have a specific marker called GPC3. This includes certain types of liver cancer, lung cancer, Merkel cell carcinoma, and a type of soft tissue sarcoma. It's a first step to see how safe the treatment is and to find the right dose. Participants will have some chemotherapy before receiving the BOXR1030 cells. You'll need to stay in hospital for the treatment and for a period afterwards, with regular check-ups over several years. The goal is to see if this new treatment can help shrink tumours.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Sotio Biotech Inc.
Enrolment target
7
Start
26 Oct 2022
Estimated completion
01 Dec 2042

What is this study about?

This study is looking for volunteers with advanced solid tumours who have a specific protein marker called GPC3 on their cancer cells. This includes certain types of liver cancer (hepatocellular carcinoma), a type of lung cancer (squamous cell carcinoma), Merkel cell carcinoma, and a specific type of soft tissue tumour called myxoid/round cell liposarcoma. If your cancer has been growing or hasn't responded to standard treatments, this study might be an option.

The main aim of this study is to test a new type of treatment called BOXR1030. This treatment uses specially modified immune cells from your own body to fight the cancer. The research team wants to understand how safe this treatment is, what side effects it might cause, and to find the best dose to use in future studies. This is a very early stage of research, so it's important to know that new treatments are not always successful.

By taking part, you would be helping doctors learn more about this new treatment and potentially help other patients in the future. The study involves regular monitoring to keep a close eye on your health and how your body responds to the treatment.

Key takeaways

  • It's a study for advanced cancers with a specific marker called GPC3.
  • It tests a new cell therapy (BOXR1030) to see if it's safe and effective.
  • You would receive some chemotherapy before the cell therapy.
  • Hospital stays are required for treatment and initial monitoring.
  • Regular check-ups will continue for many years after treatment.
  • It's an early-stage study, so new treatments are not always successful.

Who may be eligible?

To join this study, you need to be between 18 and 80 years old and weigh at least 50 kilograms (about 7 stone 12 pounds).

Your cancer must be advanced, meaning it cannot be removed by surgery or has spread to other parts of your body, and it must have a specific marker called GPC3. You will need to provide a recent sample of your tumour for testing. Your doctors must also confirm that standard treatments haven't worked well for your cancer, or you can't tolerate them.

It's important that you are generally well enough to take part, with good health in your vital organs like your heart, kidneys, and lungs. If you have liver cancer, there are also specific health criteria based on your liver function.

Quick self-check
  • Are you between 18 and 80 years old?
  • Do you weigh at least 50kg (about 7 stone 12 pounds)?
  • Has your cancer progressed or not responded to standard treatments?
  • Is your specific type of cancer (liver, lung, Merkel cell, or certain soft tissue) thought to have the GPC3 marker?
  • Do you have generally good organ health (heart, lungs, kidneys)?
  • Are you able to provide a recent tumour sample for testing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the first step is to check if your tumour has the GPC3 marker and if you meet all other health requirements. If you do, blood will be taken to collect your immune cells, which will then be sent away to create the BOXR1030 treatment specifically for you.

Before you receive the BOXR1030 treatment, you will have about three days of chemotherapy. This helps prepare your body for the new cells. You will need to be admitted to the hospital for this chemotherapy. After the chemotherapy, you'll receive the BOXR1030 treatment and will need to stay in hospital for at least 10 days afterwards so doctors can closely monitor your health. For the first month after treatment, you'll need to live close enough to the hospital that you can get there within two hours.

For the first six months after treatment, you'll have frequent hospital visits – daily at first, then less often, to check your health, look for side effects, and see how the treatment is working. You'll also need to monitor your temperature and do some simple tests at home. After six months, you will enter a long-term follow-up period, with visits scheduled less often for up to 15 years, to continue monitoring your health and the treatment's long-term effects.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your advanced cancer where standard treatments haven't worked or aren't suitable. However, as this is a new treatment, the benefits are not guaranteed and are still being investigated. There is also a risk of side effects from the chemotherapy and the BOXR1030 treatment, which your doctors will discuss with you. These could include changes to your blood, infections, or other reactions as your immune system responds. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

  • Hoag Hospital Newport Beach
    Newport Beach, United States
  • Baylor Scott and White Research Institute
    Dallas, United States
  • University of Texas MD Anderson Cancer Center
    Houston, United States
  • Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
    Seattle, United States
  • Froedtert and Medical College of Wisconsin
    Milwaukee, United States
  • Beatson Institute for Cancer Research Wolfson Wohl Cancer Research Centre
    Glasgow, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom
  • The Royal Marsden NHS Foundation Trust
    London, United Kingdom

Common questions

What is GPC3?

GPC3 is a special protein found on the surface of some cancer cells, which the new treatment is designed to target.

Will I have chemotherapy?

Yes, you will have a short course of chemotherapy before receiving the BOXR1030 treatment.

How long will I be in hospital?

You'll be in hospital for about three days for chemotherapy and then at least 10 days after receiving the BOXR1030 treatment.

How long will I be followed after the treatment?

You will be monitored regularly for 6 months after treatment, and then less often for up to 15 years.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your medical care will not be affected.

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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