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CLIC-01 Clinical Trial: Building BC Cancer’s capabilities in cutting-edge immunotherapy

BC Cancer’s immunotherapy team has developed the expertise and infrastructure to create genetically engineered immune cells for the treatment of life-threatening blood cancers.
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​Pictured (L-R): Drs. Hay, Holt and Nelson

BC Cancer’s immunotherapy team has developed the expertise and infrastructure to create genetically engineered immune cells (called CAR-T cells) for the treatment of life-threatening blood cancers. BC Cancer was the first academic group to produce and deliver CD19 CAR-T cells to cancer patients in Canada.

CAR-T cells have revolutionized the treatment of certain leukemia and lymphomas, ushering in a new era in oncology where cancer patients with advanced disease are treated with genetically engineered immune cells instead of chemotherapy and other conventional approaches. To ensure Canadian cancer patients have access to this game-changing therapy, as well as the many related innovations that promise to follow, researchers at BC Cancer developed in-house expertise and infrastructure to produce and deliver this treatment all the way from the lab bench to the patient’s bedside. In October 2019, they launched a phase I/II clinical trial (called CLIC-01) which will recruit up to 60 patients with end-stage leukemia and lymphoma who have no other treatment options available to them. In April 2020, the first BC patient was treated as part of this first academic CAR-T cell therapy trial in Canada.  

Drs. Kevin Hay, Rob Holt and Brad Nelson co-lead the BC Cancer Immunotherapy Program and the Conconi Family Immunotherapy Lab (CFIL) in Victoria, where the CAR-T cells are manufactured. The design and manufacturing of the DNA used for genetic engineering takes place at the Genome Sciences Centre (GSC) at the BC Cancer Research Institute in Vancouver. The GSC also supports logistics, project management, quality assurance/quality control, and regulatory functions of the program.  This work is primarily funded by the BC Cancer Foundation and Canada’s Networks of Centres of Excellence (BioCanRx). The Canadian Foundation for Innovation (CFI) provided support for CFIL infrastructure. 

The CLIC-01 clinical trial is a pan-Canadian effort with collaborators in Victoria, Vancouver and Ottawa working together. Dr. Hay is the lead clinical investigator in Vancouver. Over 50 patients in British Columbia and Ontario have received the therapy so far, with the trial on track to finish by the end of 2022. The availability of this therapy through the CLIC-01 trial proved especially important during the COVID-19 pandemic, when it was exceedingly difficult for patients to travel to other jurisdictions to receive this form of treatment. 

How Chimeric Antigen Receptor (CAR) T-Cell therapy Works
From the patient’s perspective, CAR-T cell therapy starts with a visit to the hospital to provide a large blood sample, which is then transported by volunteer couriers to BC Cancer’s Deeley Research Centre in Victoria. There, white blood cells are genetically engineered to express a Chimeric Antigen Receptor (CAR), which hard-wires them to recognize a protein called CD19 on cancer cells. The cell engineering process is largely automated and takes 12 days to generate a cell product that is ready for patient use. After testing for sterility and other criteria, the CAR-T cells are couriered to the Bone Marrow Transplant centre in Vancouver or Ottawa, where they are infused back into the patient’s bloodstream. Once circulating in the bloodstream, the CAR-T cells are able to recognize and kill cancer cells throughout the patient’s body. Patients receive only one infusion of cells, and they are then followed carefully by clinicians to manage any side effects and to record the clinical results.

Trial Outcomes
Outcomes data is available for the first 30 patients on the CLIC-01 clinical trial, with the 30th patient infused in October 2021. The clinical response rates have been very favourable so far, with several complete responses. Significantly, the BC Cancer-produced CAR-T cells appear to have a low rate of the common side effects seen with CAR-T cells. 

The response from the BC Cancer community regarding the trial has been incredibly enthusiastic. Due to the positive response, and the ability of the BC Cancer team’s new manufacturing capabilities, the immunotherapy team is building on the success of this first trial to develop the next generation of CAR-T cell products for leukemia, lymphomas and other cancers. 

This article was originally published in the 2021 BC Cancer Research Report.
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