Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients

Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.

NCT Number	NCT07416383
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Inflamatory Bowel Disease, Crohn Disease (CD), Ulcerative Colitis (UC)
Enrollment	40 participants
Start Date	2026-04-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-18