December 2025 STAR-BD01 Update

Dear C3 Community,

We’re pleased to share an update on the progress on the C3-led clinical trial, “STAR-BD01,” which will use Tumour Infiltrating Lymphocyte (TIL) therapy to treat people living with biliary tract cancers in Canada. This trial represents hope for many people across Canada, and we remain committed to keeping you informed with transparency to manage expectations as we move forward. From the very beginning, our goal with this trial has remained clear: to deliver the highest-quality, safest, and most scientifically robust T-cell therapy possible for our community.

Over the past year, our team, led by Dr. Simon Turcotte and supported by incredible clinical and scientific staff, has continued to refine and strengthen the manufacturing process required to produce TIL therapy. These cells need to be consistent, reliable, and able to meaningfully benefit patients. Achieving this level of quality takes time and as we'll be the first academic research group to make this therapy in Canada, we are deeply committed to doing this right the first time.

Because of this work, we are not yet ready to open the trial. While this may feel disappointing, the delay reflects progress: it means we are improving the manufacturing process to ensure that, when STAR-BD01 opens, it gives patients the very best chance at success.

We remain optimistic that 2026 will be the year we activate the trial, but at this time we are not setting a firm trial launch date. We will continue to communicate transparently as milestones are reached and timelines become clearer.

Who This Trial Is Intended For

When STAR-BD01 opens, this trial will be for:

• Patients with metastatic biliary tract cancer

• Patients who are no longer benefiting from first-line gemcitabine + cisplatin + durvalumab

• Patients who are medically fit

• Patients who have a tumor that is safely resectable to allow T-cells to be harvested and created

  
  

More details will be shared once eligibility is finalized.

While funding has been secured to support the initial cohort of 15 patients, the team remains open to additional philanthropic support that could allow more patients to be included as the program expands. Individuals or organizations interested in learning more may contact us at c3@ohri.ca.

Frequently Asked Questions

1. “If I am moving at the point where I need to decide about moving to a second-line treatment, should I wait for this trial?”

• We strongly encourage people who need second-line treatment to proceed with appropriate therapies and not wait for this trial, as long as there is no confirmed activation date.

2. "How many patients will be enrolled in this trial?"

• We plan to enroll 15 patients with biliary tract cancer into this study.

• In addition, we will include an “All Comers” cohort for a small number of patients with other metastatic solid cancers who are medically fit for TIL therapy.

3. "If the tumour we plan to remove for TIL therapy has already been treated with radiation, am I still eligible?"

• Yes, you may still be eligible. Generally, you can still take part as long as:

  • The tumour has started growing again after radiation (meaning it is truly active cancer and not just scar tissue), and

  • Your last radiation treatment to that area was at least 3 months before the planned surgery to collect tumor tissue.

• This matters because tumours that were recently treated with radiation may be damaged or may not contain enough healthy immune cells to successfully create personalized TIL therapy.

Our Commitment

We know that every delay matters to patients and families. We feel that, too. But we also know that delivering a rushed therapy will help no one. Our team is working to advance this trial as quickly and as responsibly, as possible.

Thank you to the patients, families, clinicians, donors, and partners across Canada who continue to believe in this work. Your trust fuels our determination.

We will continue sharing updates through the website as there is news to share. For the previous updates, please click here (Dec 2024) and here (April 2025).

With appreciation,

The C3 STAR-BD01 Team

For questions please contact c3@ohri.ca.