Condition: Autoimmune · Sponsor: Neukio Biotherapeutics (Shanghai) Co., Ltd.
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases. This study plans to conduct an interim data analysis when the cumulative enrollment reaches 50% of the total sample size. The objectives of this analysis are: (1) to summarize the safety and tolerability profile at the current dose level; (2) to preliminarily assess trends in clinical response endpoints and explore preliminary signals of drug efficacy; and (3) to preliminarily evaluate the pharmacokinetic and pharmacodynamic characteristics of the drug in humans. This analysis is exploratory in nature and is intended to accumulate preliminary clinical evidence for the drug in the target patient population.
This description comes directly from the study's public registry record.
Huji Xu · +86 21 8188 5514 · xuhuji@smmu.edu.cn
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| Shanghai Changzheng Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07144462