In summer 2023, Hong Kong entered the next frontier of cancer care with the launch of its first hospital-based CAR-T clinical trial. Developed entirely within city limits by a team of clinicians and scientists at the Chinese University of Hong Kong (CUHK), Prince of Wales Hospital, and the Hong Kong Institute of Biotechnology (HKIB), the study marks the first time CAR-T cells were manufactured locally and infused into patients under a formal trial protocol.
The initiative, led by Research Professor Li Chi Kong and Honorary Associate Professor Kenny Lei, has so far treated five patients – including three adults and two children – with relapsed or refractory blood cancers. It is a proof-of-concept project demonstrating that high-quality, GMP-compliant CAR-T therapy can be delivered from bench to bedside in Hong Kong. Beyond clinical impact, the programme is redefining how the city can leverage its infrastructure, talent, and translational science to improve access to advanced therapies.
Why Local Manufacturing Matters
“Some patients, whose cells had been sent abroad for processing, experienced rapid disease progression and sadly passed away before the modified cells could be returned and administered,” recalled Dr Li. The local platform was created to overcome exactly that: the multi-week turnaround and steep costs, upwards of USD 400,000, of commercial CAR-T products.
By building a semi-automated, GMP-certified process at HKIB in partnership with international centres like the Scottish National Blood Transfusion Service, the team reduced the total cell turnaround time to just two weeks. As Dr Lei noted, “This not only alleviates clinical risk but also offers psychological reassurance… It saves hospital beds, reduces reliance on interim therapies, and optimises use of limited healthcare resources.”
Treating Patients Sooner, Safer
Both physicians emphasise early intervention and inclusivity. Commercial CAR-T therapies often come with narrow criteria, available only after multiple relapses. “We designed an inclusive protocol that permits earlier intervention,” said Dr Li. “For our paediatric patients, this may spare them the long-term complications of transplantation like growth impairment and endocrine dysfunction.”
Despite cultural hesitancy towards clinical trials in Hong Kong, the trial has yielded promising results. “Our first case achieved complete molecular remission. All three adult patients remain in remission, and the treatment has been well tolerated, with only mild toxicities observed,” said Dr Lei.
Collaborative Foundation for Innovation
The success of this initiative was built on cross-disciplinary effort: CUHK’s academic leadership, HKIB’s technical capabilities, and the Hong Kong Department of Health’s regulatory openness all aligned. As Dr Li explains, “There was a unique alignment of vision across academia, government, and clinical leadership.”
Dr Lei credits a month-long observational stint at MD Anderson Cancer Center in Texas as formative: “This hands-on experience proved instrumental in shaping our own approach… backed by a committed, well-trained multidisciplinary team.”
Next Steps: A Sustainable Platform
Both doctors see potential beyond the trial. “The real achievement lies in proving our capability to develop, manufacture, and deliver cell therapy safely and effectively within Hong Kong,” said Dr Lei. While the trial is funded to treat 20 patients, the team is actively exploring hospital exemption pathways and industry collaboration to extend access.
“There are opportunities to manufacture next-generation CAR-T therapies here,” Dr Li added, “especially under Hong Kong’s ‘1+’ approval mechanism.” The platform is already engaging with biotech firms to trial more sophisticated constructs, including those targeting solid tumours.
This first-in-city CAR-T initiative not only demonstrates technical and clinical feasibility; it also lays the groundwork for Hong Kong to become a nimble and credible contributor to the global development of advanced therapeutics.
