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Longyao Bio's new CAR-T and general-purpose CAR-T clinical research programs have passed the ethics review of Jiangsu Provincial People's Hospital and Xu Medical Affiliated Hospital respectively

2019-08-13

Recently, Longyao Bio's " Clinical Study of Novel Autologous CAR-T in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma " and " Clinical Study of UCAR-T in the Treatment of Acute B-Lymphocytic Leukemia (B-ALL) " projects They passed the review by the Ethics Committee of Jiangsu Provincial People's Hospital and the Ethics Committee of Affiliated Hospital of Xuzhou Medical University respectively, and obtained the ethics approval. This marks that Longyao Bio's new autologous CAR-T and UCAR-T clinical research projects have officially entered the stage of exploratory clinical treatment trials.

Jiangsu Provincial People's Hospital is a national drug clinical trial institution (GCP base), which has advantages in clinical research, facility services, and talent training. .

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The Hematology and Oncology Center of the Affiliated Hospital of Xuzhou Medical University is a key medical discipline and a key clinical specialty in Jiangsu Province. It has undertaken the construction of multiple platforms of the Jiangsu Provincial Department of Science and Technology, the Health and Family Planning Commission, and the National Development and Reform Commission, and is well-known both inside and outside the province. Its ethics committee is also accredited by FERCAP International.

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The scientific and ethical experts participating in the two institutes fully carried out the scientificity of the project and the completed preclinical research, including cell preparation and quality research, cell pharmacy research, safety evaluation, efficacy evaluation, third-party compound inspection, etc. Demonstration, fully affirmed the scientific progress and preliminary exploration of the project, and at the same time gave suggestions on the implementation plan of the project, providing a stronger scientific and ethical guarantee for the filing and implementation of the later project.

The experimental project carried out by Longyao Biology, Jiangsu Provincial People's Hospital and Xu Medical Affiliated Hospital willLongyao Bio's new autologous CAR-T and UCAR - cell technologies are applied in basic clinical research practice, and in the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma and acute B-lymphocytic leukemia, reflecting Longyao 's role as a The obligatory social responsibility of an excellent biotech enterprise has also brought new hope to the majority of patients with acute B lymphocytic leukemia.