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FDA Grants Clearance to Clinical Trial for NK CellTech’s Non-Genetically Modified Natural Killer Cells


NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.

3d rendered medically accurate illustration of leukocytes attacking a cancer cell. Image Credit: Adobe Stock Images/SciePro

Image Credit: Adobe Stock Images/SciePro

Last week, NK CellTech Co., Ltd announced that the FDA officially granted clearance for its clinical trial for NK010, a non-genetically modified natural killer (NK) cell therapy. According to NK CellTech Co, the therapy is the first non-genetically modified NK cell derived from allogeneic peripheral blood cell (PBMC) developed by a China-based company to be cleared for clinical trial by the FDA. Reportedly, the benefits include multiple high anti-tumor advantages, including a wide spectrum and high expression of NK cell activation receptors and high purity.1

For its Phase I clinical trial, NK CellTech chose to focus on ovarian cancer, stating that in pre-clinical studies in animal models, the therapy displayed great potential in inhibiting strong tumor growth on ovarian cancers.1

"We are thrilled and proud to receive FDA clearance for the clinical trial of NK010," said Zhigang Tian, founder, NK CellTech, member of the Chinse Academy of Engineering and the Academia Europaea, in a company press release. "NK010 has demonstrated promising anti-tumor activity and safety in preclinical studies. We have great confidence in its potential to treat solid tumors. Yet, there is still a lot left to explore, and our team has remained on our mission to revolutionize cancer treatment through innovative cellular therapies and fulfill the unmet clinical needs in the future."

NK cells have been used in the treatment of other various forms of cancer and Alzheimer disease. According to an article published by Labiotech, treatment with NK cells works by drawing blood from a patient, which lab workers then enhance before infusing them back into the patient’s body. NKGen’s clinical program product candidate, SNK01, includes a non-genetically modified NK cell with the focus on treating moderate Alzheimer disease.2

Additionally, companies such as Artiva Biotherapeutics have advanced research efforts in the NK space. In a podcast interview with Jim Cornall of Labiotech, Fred Aslan, MD, CEO, Artiva Biotherapeutics, discussed two of the company’s cancer clinical trials that have shown the possibilities when it comes to efficacy and safety with NK. AlloNK (AB-101), the company’s non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate, was being investigated in a Phase I/II multicenter clinical trial for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. AB-201, another NK cell therapy candidate developed by Artiva, focuses on the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers. The FDA previously accepted an investigational new drug application for the treatment.3


1. NK CellTech Announces FDA Clearance for Clinical Trial of NK010. PR Newswire. January 22, 2024. Accessed January 22, 2024. https://www.prnewswire.com/news-releases/nk-celltech-announces-fda-clearance-for-clinical-trial-of-nk010-302040625.html

2. Could natural killer cells transform Alzheimer’s treatment? Labiotech. January 12, 2024. Accessed January 22, 2024. https://www.labiotech.eu/podcast/natural-killer-cells-alzheimers-treatment/

3.Beyond Biotech podcast 67 – natural killer cells. Labiotech. October 13, 2023. Accessed January 22, 2024. https://www.labiotech.eu/podcast/beyond-biotech-podcast-67-natural-killer-cells/

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