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Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products Draft Guidance for Industry was launched by FDA on March 21, 2022. It provides CAR-T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, clinical study design, and other important aspects. To provide references for sponsors, this article mainly introduces the clinical considerations for early-phase development of CAR-T cells for patients with cancer (hematologic malignancies and solid tumors), including study population, treatment plan, clinical pharmacology considerations, safety evaluation and monitoring, CAR-T cell persistence and long term follow-up, and allogeneic CAR-T cells. This article also introduces the information of chimeric antigen receptor T cell products in China, and discusses the similarities and differences of the clinical review of such products by regulatory agencies between China and the United States.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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