When Dr Nada Hamad started as the Director of Haematology Clinical Trials Unit at St Vincent’s Hospital in Sydney, the hospital didn’t have the facilities for the novel strategy of using CART cells to treat lymphoma. CART cell therapies work by collecting natural T-cells from a patient, modifying them to target a specific cancer, and readministering the modified cells. Now, thanks to a huge organisation-wide commitment, the hospital has the capability for CART cell therapy delivery and is participating in clinical trials, including the phase III BELINDA study which aims to compare standard of care with earlier use of CART cell therapy in relapsed or refractory aggressive non Hodgkin lymphoma.

Setting up an entire hospital to be compatible with a novel complex therapy

Dr Hamad and the team at St Vincent’s Darlinghurst were increasingly aware that access to CART-cell therapy was not possible outside of clinical trials and these were very rare for lymphoma indications.

“If I want to set up a clinical trial, I need to look at it, look at the protocol, say ‘yes its feasible’ yes it’s going to work, we have the right clinical trial staff. But for CART cell therapies, you have to get your entire hospital to not only learn about cellular therapies, but to engage, and to commit to quality service provision using this complex treatment strategy. And that... oh, that was hard,” Dr Hamad laughed.

Many speciality departments and the hospital executive of the hospital needed to be on board for this trial to happen. Dr Hamad recalls calling neurologists and radiologists and asking if they would be happy to be called in the middle of the night if complications arose. Each member of staff in every clinical category was required to undergo training and be available on a 24 hour roster to take phone calls for any challenges that may arise.

The demand for these therapies in NSW was surprisingly high, and the need for wide-spread engagement was unexpected. Luckily, the team is now part of one of only three centres in NSW delivering CART therapy and one of 3 centres in Australia participating in the Belinda study.

“I’m proud that I work in a hospital where people were so open to someone they never met coming in and saying ‘we would like to conduct a very complex trial and can you please help us on a 24 hour basis. I am proud of the members of the team we put together. Collaborating with others in such a unique way to deliver such cutting edge technology was exciting and incredibly satisfying. “To set up a clinical trial in T-cell therapy when you don’t even have a T cell therapy program! - That was an extraordinary feat,” said Dr Hamad.

The BELINDA Study

Once the hospital was equipped to begin work with the novel therapy, the team got to work on facilitating a clinical trial. The BELINDA study is a stage III trial assessing the efficiency of Chimeric Antigen Receptor T-Cells (CART) in patients who have aggressive B-Cell Non-Hodgkin Lymphoma. One in three patients with the disease will not respond or will relapse after frontline treatment—making the need for novel therapies a high priority.

The BELINDA study was approved in 2019 and applies an internationally commercially-available CART cell therapy in aggressive Non Hodgkin Lymphoma. By using an existing product, the team at St Vincent’s would have access to a cutting-edge, novel therapy for patients earlier than they would normally, if at all.

“We found that people were trying to cross-refer across the country to us to gain access to these products; there was extraordinary demand. To me, being able to offer cutting edge therapies to patients in need and close to home is the highlight of my work here at St V’s,” said Dr Hamad