RecruitingPHASE1INTERVENTIONAL

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours

This study is looking into a new treatment called GCAR1 for people in Canada with specific types of advanced cancer, including a rare bone cancer (Alveolar Soft Part Sarcoma), certain kidney cancers (Renal Cell Carcinoma), and Triple Negative Breast Cancer. The main goal is to find the safest and most effective dose of GCAR1. This treatment is a type of 'CAR-T cell therapy', which uses your own immune cells to find and fight cancer. Researchers have seen in lab tests that GCAR1 might help the immune system recognise cancer cells and potentially slow their growth. The study aims to see if these promising lab results translate into benefits for patients.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Canadian Cancer Trials Group

Enrolment target

Start

30 Jun 2026

Estimated completion

01 Sep 2033

Alveolar Soft Part Sarcoma Renal Cell Carcinoma Triple Negative Breast Cancer

What is this study about?

This study is investigating a new type of cancer treatment called GCAR1. It's a special kind of therapy that uses your body's own immune system to fight cancer. Think of it like this: your immune system has 'fighter cells' that normally protect you from infections. Scientists can now take some of these fighter cells from your blood, modify them in a lab so they become really good at spotting cancer cells, and then put them back into your body.

The GCAR1 treatment works by teaching these fighter cells to recognise a particular protein called GPNMB, which is found on the surface of certain cancer cells. By spotting this protein, the modified immune cells can then target and attack the cancer cells. This research is important because it could lead to new ways to treat cancers that are difficult to treat with current methods. The study is currently focused on finding the right amount (dose) of GCAR1 that can be given safely without causing too many severe side effects, and to see if it has a positive effect on the cancer.

The specific cancers being looked at in this study are Alveolar Soft Part Sarcoma (a rare soft tissue cancer), certain types of Renal Cell Carcinoma (a kidney cancer), and Triple Negative Breast Cancer. For people with these advanced cancers where other treatments haven't worked or are no longer an option, this new approach could offer hope. It's a first step in understanding how well this innovative therapy might work in people.

Key takeaways

This is an early-stage (Phase 1) study for a new cancer treatment.
It uses your own modified immune cells (CAR-T therapy) to target cancer.
The study currently only accepts patients in Canada.
It targets specific advanced cancers: a rare bone cancer, certain kidney cancers, and Triple Negative Breast Cancer.
The main aims are to find the safest dose and see early signs of effectiveness.
Your cancer must have a specific protein called GPNMB to be eligible.

Who may be eligible?

This study is looking for adults with specific types of advanced cancer in Canada. This includes Alveolar Soft Part Sarcoma, certain kinds of Triple Negative Breast Cancer, and particular types of Renal Cell Carcinoma. It's important that your cancer has a protein called GPNMB on its cells, which will be checked using a sample of your tumour.

You would generally be considered if your cancer has spread, come back after treatment, or can't be removed with surgery, and if standard treatments haven't worked or are no longer suitable for you. You also need to be well enough to take part, meaning you can mostly look after yourself and manage daily activities with little to no help.

There are specific requirements for previous treatments, depending on your cancer type. For example, people with Triple Negative Breast Cancer will have had certain chemotherapy and other treatments. Your medical team will help determine if you meet all the detailed criteria, including things like your overall health and how much time has passed since your last treatment.

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.

Do I have Alveolar Soft Part Sarcoma, a certain type of Renal Cell Carcinoma, or Triple Negative Breast Cancer?
Has my cancer spread, returned, or can it not be removed by surgery?
Have I already tried other standard treatments for my cancer?
Am I generally well enough to manage my daily activities (ECOG 0 or 1)?
Is my tumour confirmed to have the GPNMB protein?
Am I eligible for treatment in Canada?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have a detailed check-up to make sure you are suitable. This will involve giving blood samples, having scans (like X-rays or CT scans), and providing a sample of your tumour tissue. If eligible, blood will be taken from you to create your special GCAR1 immune cells. While these cells are being prepared in the lab, you will likely receive some chemotherapy through a drip to prepare your body for the new cells.

After this, you will receive the GCAR1 cells, also through a drip. You will then be closely monitored in the hospital for a period to watch for any side effects. You'll have regular follow-up appointments, which will include more blood tests and scans, to see how you are responding to the treatment and to keep an eye on your general health. The exact number of visits and tests will vary, but participation will involve hospital stays and regular clinic visits for an extended period, potentially over several months or longer.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. The potential benefit of this study is thatGCAR1 is a new treatment which may help slow down or control your cancer, especially if other treatments haven't worked for you. However, there's no guarantee the treatment will work for everyone, and it might not improve your condition. Potential risks include side effects from the chemotherapy you receive before GCAR1, and side effects from GCAR1 itself, which can sometimes be serious, as your immune system is being activated. These could include fever, fatigue, and other more specific reactions that your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is CAR-T cell therapy?

CAR-T cell therapy is a special treatment that uses your own immune cells, specifically modified in a lab, to find and fight cancer cells in your body.

Which types of cancer is this study for?

This study is for specific advanced cancers: Alveolar Soft Part Sarcoma, certain kinds of Renal Cell Carcinoma, and Triple Negative Breast Cancer.

Why is GPNMB important for this study?

GCAR1 is designed to recognise a protein called GPNMB on cancer cells. So, your cancer must have this protein for the treatment to work.

Where is this study taking place?

This study is only open to patients in Canada.

What is the main goal of this study?

The main goal is to find the safest dose of GCAR1 and to see if it helps people with these specific cancers.

How to find out more

Laura Pearce

lpearce@ctg.queensu.ca 613-533-6430 Official trial record

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