Multiple myeloma is a liquid cancer derived from malignant plasma cells in bone marrow. This cancer has a high incidence in the US. Precision immunotherapy like CAR-T has been shown to be very effective in treating leukaemias and lymphomas. Nanjing Biotech has invented a specific CAR-T planned form which we are using to treat relapsed or refractory multiple myeloma patients. In our current ongoing trial we have observed a revolutionary quick and durable remission in most multiple myeloma patients. We first screened and enrolled patients then isolated immune cells from patients and engineered the CAR molecule in the lumbar. This is just like placing a GPS on the immune T-cells which now can [?? 1:21] fighting cancer cells. We call this unique CAR design LCAR-B38M. In our hospital patients were infused with three doses of engineered T-cells at day zero, two and six. You can see on the left half of the slide the CAR T-cells now bound to myeloma cells under the microscope.
So far 35 multiple myeloma patients have been treated in our CAR-T trial. First there are 19 patients who were treated and four months ago in these 19 patients 14 patients had reached a stringent complete response, SCR, based on the International Myeloma Working Group criteria. When we submitted our ASCO initial abstract in February this year this number was six but now the number has reached 14. In other words, during the past three months CR rate has increased from 19.2% to 74%. There are six additional patients who have reached a very good partial remission criteria, very good PR. This shows very clearly that while time goes on the therapeutic efficacy improves progressively.
Second, there are four patients who received the treatment for more than one year. These four patients all remain in SCR. As of today there are no T-cell relapses among patients who have reached SCR. Lastly, there are six patients who have been treated for less than four months. They have showed various degrees of response.
Safety is our [?? 4:04] unlike what has been seen in ARR CAR-T trials, we have never observed any sign of neurotoxicity, including cerebral oedema. We also observed much milder cytokine release syndromes, CRS, than frequently reported in the [?? 4:31] CAR-T trial done by others. Among our 35 patients 6 patients were free of any CRS, 17 patients had grade 1, 10 patients had grade 2 CRS. There are only two patients who experienced grade 3; there is no grade 4 or 5 CRS and there are no treatment related deaths.
In summary, our result has shown a quick and reproducible therapeutic efficacy in refractory or relapsed multiple myeloma disease. Longer term follow up of early treatment patients shows a durable and stringent complete remission. Our technology is not only efficacious but also very safe. USND has been planned and the technology will be validated in the US under regulation of the FDA. Thank you very much.
For questions regarding to the production you may ask Dr Frank Fan of the Legend Biotech. Thank you again.
