US Clinical Trial NCT03941262

Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Participants With Pathologically Confirmed Cancer Refractory to Conventional Therapy  May 3, 2019

Nine (9) participants, male or female, aged 18 years or older will be enrolled in the study, all of whom will receive "SNK01" without placebo control. There are three (3) subjects in each of the three (3) cohorts. The SNK01 study product will be administered at the following doses using dose escalating rules: Cohort 1 will receive 1 billion cells, Cohort 2 will receive 2 billion cells, and Cohort 3 will receive 4 billion cells. Length of participation, per participant, is approximately 9 weeks. The primary endpoint is safety: incidence and severity of dose-limiting toxicities (DLT's), adverse events, vital signs, physical examination, and clinical laboratory tests. The secondary endpoint is preliminary efficacy defined by objective response rate (ORR): the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR).

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Keywords
Malignant Neoplasm

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Source:  NIH Last updated:  Jun 12, 2019

From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.