Complete Remission Rate of 90%: China-based CAR-T Cell Therapy Achieves Breakthrough Clinical Trial Results

The trial, jointly conducted by the hospital and the company Innovative Cellular Therapeutics (ICT), obtained clinical ethics approval and enrolled its first patient in June 2015. By April 2016, the tenth patient achieved complete remission.

During the 10 months of the trial, the research team finished CAR-T cell reinfusion and conducted preliminary evaluation of ten patients suffering from relapsed or refractory B lymphoblastic leukemia.

The clinical trial was conducted in strict accordance with clinical ethical standards and monitored independently by a third-party clinical research organization. All patient expenses incurred by the CAR-T trial were reimbursed by ICT. Nine out of the ten patients achieved complete remission, and the minimal residual disease (MRD) in 8 patients turned negative, a significant indication of curative effect. Both the complete remission rate of 90% and the MRD-negative rate of 80% out-performed the best results recorded worldwide to date.

All ten patients, ranging in age from 17 to 57, suffered from relapsed or refractory B lymphocytic leukemia and were expected to live only several months. The tenth and final patient is a 17-year-old female who enrolled in the CAR-T clinical trial in March of this year. After collecting her blood, researchers performed a genetic transformation of her common T-cells to express a molecule called Chimeric Antigen Receptor (CAR). Similar to GPS, CAR can guide specific T-cells to track, identify and kill malignant tumor cells. Through the application of this technology, common T-cells were transformed into "cancer fighting" CAR-T cells.

In early April 2016, the transformed CAR-T cells were infused into the body of the patient, and the 'cytokine storm' took place as the research team had expected. As the CAR-T cells rapidly proliferated in the patient's body and released a large number of cytokines, the patient experienced symptoms that included fever, muscle pain and hypoxemia. These symptoms indicated that the introduction of CAR-T cells was having a positive effect. The subsequent test results showed that she was in complete remission and she was identified as MRD-negative.

Innovative Cellular Therapeutics, in collaboration with the First Affiliated Hospital of Zhejiang University, achieved success in the evolution of CAR-T therapy. ICT is conducting clinical trials on relapsed and refractory acute lymphocytic leukemia in seven other hospitals across China and has completed the trial and initial data collection of 23 patients suffering from an advanced stage of the disease. Twenty patients, or 87% of the total trial population, enjoyed complete remission of leukemia.

Before the trial, only three firms in the world (Novartis, Juno and Kite Pharma), all based in the U.S., have developed similar levels of CAR-T therapy for leukemia. ICT, a Chinese firm, has now joined that distinguished group to become one of the global leaders in the application of CAR-T therapy.

Based on the success of its leukemia trial, ICT will next set its sights on a new clinical trial for the treatment of lymphoma. Looking ahead, ICT will focus its R&D efforts on solid tumors including colorectal cancer, breast cancer, gastric cancer and esophageal cancer.

CAR-T cellular therapy is rapidly gaining the attention of doctors, researchers, patients, and the public at large as the most promising tumor precision therapy in the world and it is expected to benefit more patients afflicted with tumors in the future.