June 2016: Professor Huang He of Zhejiang University’s First Affiliated Hospital presented the outcomes of 10 clinical cases including CAR-T cell therapy for leukaemia treatment at the 2016 Haematogenic Immunity Summit in Hangzhou from April 22 to 24, 2016. This is the first time that the entire clinical trial data set has been made publicly available.
The trial, which was co-led by the hospital and Innovative Cellular Therapeutics (ICT), received clinical ethics approval in June 2015 and recruited its first patient. The tenth patient had achieved complete remission by April 2016.
The study team completed CAR-T cell reinfusion and conducted preliminary evaluations on ten patients with relapsed or refractory B lymphoblastic leukaemia during the 10-month clinical trials.
A third-party clinical research organisation independently oversaw the clinical trial, which was done in strict conformity with clinical ethical guidelines. ICT covered all patient costs associated with the CAR-T experiment. Nine of the ten patients obtained complete remission, and the minimal residual disease (MRD) in eight of them became negative, indicating that the treatment was effective. Both the complete remission rate of 90% and the MRD-negative rate of 80% were higher than the greatest outcomes ever recorded globally.
All ten patients, who ranged in age from 17 to 57, had relapsed or refractory B lymphocytic leukaemia and were given only a few months to live. The tenth and final patient is a 17-year-old woman who began participating in the CAR-T clinical trial in March of this year. Following the collection of her blood, researchers genetically modified her common T-cells to express a protein known as Chimeric Antigen Receptor (CAR). CAR can direct specific T-cells to locate, identify, and kill malignant tumour cells in the same way as GPS can. Common T-cells were turned into “cancer-fighting” CAR-T cells thanks to the use of this technology.
The modified CAR-T cells were administered into the patient’s body in early April 2016, and the ‘cytokine storm’ occurred as predicted by the study team. The patient developed symptoms such as fever, muscle soreness, and hypoxemia as the CAR-T cells rapidly expanded in his body and generated a huge amount of cytokines. These signs suggested that the use of CAR-T cells was having a beneficial effect. She was found to be MRD-negative after the further tests revealed that she was in complete remission.
Innovative Cellular Therapeutics, in partnership with Zhejiang University’s First Affiliated Hospital, has made significant progress in the development of CAR-T therapy. ICT is conducting clinical studies at seven different institutions around China for relapsed and refractory acute lymphocytic leukaemia, and has finished the trial and collected preliminary data on 23 patients with severe disease. Twenty individuals, or 87 percent of the overall study population, experienced complete leukaemia remission.
Only three companies in the world (Novartis, Juno, and Kite Pharma), all based in the United States, had developed similar levels of CAR-T treatment for leukaemia prior to the trial. ICT, a Chinese company, has now joined that illustrious company as one of the global leaders in CAR-T treatment application.
ICT will now focus on a new clinical trial for the treatment of lymphoma, based on the results of its leukaemia trial. In the future, ICT will concentrate its research and development efforts on solid tumours such as colorectal cancer, breast cancer, gastric cancer, and esophageal cancer.
CAR-T cellular therapy is quickly gaining traction among doctors, researchers, patients, and the general public as the world’s most promising tumour precision medicine, and it is predicted to benefit more patients with cancers in the future.