The first two CCTG led cell therapy trials are now open in Canada

Wednesday, July 08, 2026

CCTG is committed to the evaluation of innovative cell therapy products, strategies to improve cell therapy outcomes and to advancing accessibility for Canadian patients.

“The exciting launch of these first two trials involving cell therapies is the result of years of work and investment by many,” says Dr. Annette Hay, CCTG Senior Investigator. “We are excited to deliver on the strong foundation that has been built, to complete these studies, and develop new trials as we continue to work towards improved outcomes for Canadians with cancer.”

The IND246 study is a phase I trial evaluating increasing dose levels of GCAR1 to determine a safe and effective dose for further testing.

GCAR1 is a novel chimeric antigen receptor T (CAR T) cell therapy developed by researchers at the University of Calgary, Riddell Centre for Cancer Immunotherapy in collaboration with other researchers and institutions across Canada. It is designed to target GPNMB, a protein found on the surface of cancer cells in some types of solid cancers. Pre-clinical studies have shown that GCAR1 may help the immune system recognize and attack cancer cells, potentially slowing tumour growth.

"We have studied GCAR1 in single patient trials in Calgary and we are excited to now offer this therapy through a multi center phase I trial at sites across the country,” says Dr. Mona Shafey study chair and Clinical Associate Professor, Department of Medicine - Division of Hematology, University of Calgary, Director, Alberta Blood & Marrow Transplant Program at Arthur Child Comprehensive Cancer Centre.

The primary goal of this study is to identify the highest dose of GCAR1 that can be administered safely without causing unacceptable side effects. Researchers will also evaluate how the therapy affects cancer growth and response.

Researchers hope this innovative therapy will provide a new treatment option for patients with limited alternatives, while also generating valuable biological data to inform how cancers respond to treatment.

IND245 is a trial evaluating the addition of sonrotoclax and zanubrutinib in patients with mantle cell lymphoma (MCL) who are scheduled to receive standard of care CAR-T cell therapy. CAR-T can be very challenging in patients with relapsed or refractory MCL as many have resistance to BTK inhibitors used to stop cancerous cells from multiplying.

About inhibitors

BTK inhibitors are targeted medications that block BTK enzyme in B cells (a type of white blood cell) and act as a roadblock to stop cancerous B cells from multiplying.

BCL-2 inhibitors are targeted anti-cancer drugs that restore the body's natural cell-death process (apoptosis) by blocking pro-survival proteins, these drugs cause tumor cells to self-destruct.

“There are emerging data that continuing BTK inhibitors before and after CAR-T, even when the MCL is resistant, is associated with reduced toxicity,” says Dr. Diego Villa co-chair of the study and medical oncologist at the BC Cancer – Vancouver. “Adding sonrotoclax, a novel BCL-2 inhibitor, may provide the necessary disease control required to set up patients for improved outcomes with CAR-T.”

Researchers believe that combining sonrotoclax, a BCL-2 inhibitor, with zanubrutinib, a BTK inhibitor, may improve responses to CAR-T cell therapy while reducing treatment-related toxicity. This phase II study will assess the impact of using these oral medications before CAR-T therapy and continuing zanubrutinib after treatment to determine whether this strategy leads to better outcomes for patients.

“The hope is that cell therapy will benefit patients and ultimately provide a much-needed treatment option for patients these types of cancer as well as reducing the side-effects of treatment,” says CCTG Patient Representative Carol Hill.

The use of CAR-T and related cell therapies will continue to grow, and these early-stage studies will have significant impact on patients if proven successful through clinical trials.

IND245

IND246