CAR T-cell therapy trials to commence in HK
Clinical trials of chimeric antigen receptor (CAR) T-cell therapy in haematological malignancies are to commence in Hong Kong following completion of the city’s first CAR T-cell laboratory to be built by the Chinese University of Hong Kong (CUHK).
“Construction of the CAR T-cell laboratory is expected to be completed in 2020. Clinical trials will commence once Good Manufacturing Practice [GMP] license is obtained,” said Dr Daniel Lee, Associate Vice-President (Innovation and Enterprise) of CUHK.
“Our first clinical trial will be conducted in paediatric and adult patients with relapsed or refractory CD19-positive acute lymphoblastic leukaemia [ALL] or lymphoma, using CD19 CAR T-cells produced at the CUHK GMP facility,” said Professor Chi-Kong Li of the Department of Paediatrics, CUHK. “In this pilot study, the efficacy of the CD19 CAR T-cells in achieving disease control and cure, with or without stem cell transplantation, will be evaluated in 10 patients.”
“Subsequent clinical trials at our centre will look at extending CAR T-cell therapy to other types of cancer, including solid tumours,” Li added.
The research programme will involve collaboration between CUHK, Prince of Wales Hospital (PWH), and the Hong Kong Science and Technology Parks Corporation. “A laboratory spanning 3,000 square feet will be built by the third quarter of 2020 to treat 10–20 patients per year. Another facility spanning 20,000 square feet will be built subsequently to treat about 100 patients per year,” said Lee.
At present, two CD19 CAR T-cell products are approved by the US FDA for treatment of leukaemia and lymphoma. “While promising long-term survival outcomes have been reported, these therapies are available at selected centres only, with a treatment cost of up to USD 1 million,” Li noted.
With a local facility producing CAR T-cells that fulfill stringent quality and safety requirements, Li expects that the overall cost of treatment will come down to below HKD 1 million.
CAR T-cell therapy, which involves genetic modification of patients’ T-cells to recognize and destroy cancer cells, is a new immunotherapeutic option for those with relapsed or refractory haematological malignancies despite systemic treatment or stem cell transplantation.
“In patients with haematological malignancies, the cure rate with chemotherapy is 30–80 percent and that with haematopoietic stem cell transplantation is 30–60 percent,” noted Li. “Haematopoietic stem cell transplantation is used as salvage therapy after chemotherapy failure, and is associated with significant early and late complications.”“Several paediatric leukaemia patients of PWH have already received CAR T-cell therapy in mainland China and the US,” said Li. “One of the patients, a young boy diagnosed with ALL at 21 months of age, experienced bone marrow relapses in April 2018 and February 2019 despite chemotherapy and subsequent unrelated umbilical cord blood transplantation. The patient received CAR T-cell therapy in Shanghai in March 2019 and has remained in remission since then.”