STAR-BD01 Trial Updates

Dear C3 Community,

 

We’re excited to share updates on the C3-led clinical trial, “STAR-BD01”, which will use Tumor Infiltrating Lymphocytes (TIL) therapy to treat biliary tract cancers. We know this trial represents hope for many, and we’re committed to keeping you informed about our progress, challenges, and next steps.

 

TIL therapy is a form of personalized cell therapy that has shown promising results across various cancer types, including cholangiocarcinoma. Currently, there are no “investigator-initiated” trials in Canada that use TIL therapy, making STAR-BD01 a groundbreaking effort. The STAR-BD01 lead investigator, Dr. Simon Turcotte, brings over 15 years of experience with TIL therapy, having been part of its original development at the National Institutes of Health in the US. With this expertise, the C3 clinical trial team is developing a modified version of TIL, called “dual-selected” TIL, and we’re eager to bring this treatment to Canada.

 

Launching a TIL therapy trial requires two key milestones:

1. Designing a scientifically rigorous clinical trial.

2. Establishing a Health Canada-approved TIL manufacturing process.

 

We’ve made significant progress on both fronts. The clinical trial design has undergone multiple reviews by local and international experts, including medical oncologists, patient partners, and clinical trial specialists. Our TIL manufacturing plan has also been reviewed and approved by Health Canada, and we are currently conducting pilot manufacturing runs to gather data for final regulatory approval. This is currently where our efforts are focused.

 

We initially aimed to launch the trial by late 2024; however, we now anticipate a delay as we continue gathering essential pilot manufacturing data required for final approval from Health Canada. We understand this news may be disappointing, but ensuring the manufacturing process and trial design are scientifically robust is crucial to maximizing the trial's success. We now plan to launch the trial in Q3 or Q4 of 2025 and will share a confirmed date as we make further progress.

 

We remain fully committed to advancing this important research. Going forward, we’ll provide quarterly updates through newsletters and our website to keep you informed. Your ongoing support inspires our team, and we thank you for your patience and trust as we work to bring this promising therapy to patients in Canada.

 

Warmest regards,

The C3 Clinical Trial Team