NCT Number: NCT07416383
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CNK-UT009 is a type of independent development universal cell therapy agent, the reagent would be injected intravenously. We set three preset dose levels (3*7E positive cells/kg 、6*7E positive cells/kg 和 1*8E positive cells/kg) with a tapering dose of 1.5*7E positive cells/kg. Total cells would be divided into several parts and be given in the cycle of two weeks, adjusted by the tolerance and adverse effects of our patients.
Time frame: 12 weeks after first injection
indicate the safty
Time frame: 12 weeks after first injection
indicate the safety
Time frame: 12 weeks
rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect)
Time frame: 12 weeks
take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009
Time frame: 12 weeks
rate of clinical remission patients after EOT-I(end of induction treatment phase), rate of endoscopic remission patients after EOT-I.
Time frame: 52 weeks after the first injection
rate of clinical remission patients and rate of endoscopic remission patients in the maintaining period, rate of glucocoticoid-free patient
Time frame: 12weeks and 52 weeks
analyse immune cell components and levels of cytokines in blood samples to describe the influence on immune environments of CNK-UT009 cells.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
An Exploratory Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetics of the Universal CNK-UT009 Cell Injection in Subjects With Difficult-to-treat Inflammatory Bowel Disease
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