Imagine if you could re-engineer your immune system to target and attack cancer growing in your body. A new clinical trial led by a clinician researcher at the University of Alberta is doing just that.
Michael Chu, an assistant professor of oncology in the Faculty of Medicine & Dentistry, is leading a project to manufacture and test locally produced chimeric antigen receptor (CAR) T-cells for the treatment of leukemia and lymphoma.
CAR T-cell therapy is an innovative treatment that uses a patient’s own immune system to battle cancer cells. It’s a promising alternative to common treatments such as chemotherapy, radiation or surgery, and can be the only viable option for some patients.
"One of the big problems with most cancers in people is that their immune system has a strange defect in that they can't recognize cancer cells,” said Chu. “CAR T-cells get around that by genetically manipulating the immune system."
Until now, CAR T-cells were not manufactured in Alberta, making treatment difficult to access and incredibly costly. In the trial, cells are being produced at the U of A’s Alberta Cell Therapy Manufacturing (ACTM) facility along with another facility in Calgary. It is expected up to 60 patients a year will benefit from the treatment as part of the province’s new CAR T-cell therapy program, with patients receiving treatment at Edmonton’s Cross Cancer Institute, and Calgary’s Tom Baker Cancer Centre and Alberta Children’s Hospital.
The project is supported by the Alberta government and the Alberta Cancer Foundation, who announced last August that they would be joining forces to provide $15 million in funding for the trial. In addition to funding the clinical trial itself, the funds will also be used for nursing staff, training and education for health-care workers, lab and diagnostic imaging, followup care, and patient education and psychosocial support. Over the last decade, additional support to make the treatment a reality has been provided by the University Hospital Foundation, Cure Cancer Foundation, Allard Foundation, Myeloma Alberta Support Society and thousands of individual donors.
There are numerous benefits of having the cells crafted in Edmonton rather than abroad, said Chu, who is also a member of the Cancer Research Institute of Northern Alberta (CRINA).
The first, on a practical level, is cost. According to Chu, CAR T-cells can be manufactured for about C$55,000 per patient, whereas current pharmaceutical treatments cost nearly half a million per patient.
The ability to craft cells in-house also allows the therapy to be more customizable.
“This is a great example of precision medicine. While we are targeting a particular bar code on cancer cells, that’s not necessarily the right bar code for everyone. By creating a program like this, in the future, this will allow us to customize a cell therapy product for a patient,” said Chu.
There’s also a possibility that having the cells available locally will yield higher-quality cells for treatment. Until now, pharmaceutical versions of CAR T-cells used in Edmonton have been produced elsewhere and needed to be frozen before transport. Creating the cells locally eliminates this need, Chu said, and there’s a theory that the fresh CAR T-cells may be even more effective than treatments in which the cells must be frozen and transported before use.
Alberta would be just the third province to offer CAR T-cell therapy, which is also available in Ontario and Quebec.
Chu is leading a clinical trial with 57 patients that got underway this spring, and the team should have valuable data within about nine months of the trial’s launch about the efficacy and safety of the therapy. The first stages involve collecting participating patients’ T-cells for manufacturing before dosing the patients with the therapy. Data from other trials suggest that a relapse after CAR T-cell therapy generally happens within three to six months, which means patients who haven’t relapsed within that time frame will likely have good outcomes.
While the initial clinical trial will focus on crafting CAR T-cells for patients with leukemia and lymphoma, Chu said having this type of treatment accessible in Edmonton holds exciting possibilities for many more patients.
“I think of this as a stepping stone in the sense that it establishes the workflow and manufacturing credibility and validity so that we can then create cell therapies for other cancers, and also non-cancerous illnesses,” said Chu.
“Cell therapy and immune therapy is the wave of the future—this is going to replace a lot of the treatments that we currently use.”