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.
diagnosed moderate-to- severe IBD patients
defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)
with complete bone-marrow and organic function
no pregnant or planning to become pregnant
patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)
patients paticipated other clinical trials with four weeks
patients with drug combination other than low-dose glucocotiod
patients recieved abdominal surgery or live vaccine
Single group
injection of CNK-UT009
DrugCNK-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.
maximum tolerant dose(MTD)
indicate the safty
rate of DLT(dose-limiting toxicity)
indicate the safety
adverse effects of CNK-UT009
rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect)
pharmacokinetics of CNK-UT009
take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009
preliminary efficacy of CNK-UT009
rate of clinical remission patients after EOT-I(end of induction treatment phase), rate of endoscopic remission patients after EOT-I.
exploratory endpoint include long-term efficacy
rate of clinical remission patients and rate of endoscopic remission patients in the maintaining period, rate of glucocoticoid-free patient
influence of immune environment
analyse immune cell components and levels of cytokines in blood samples to describe the influence on immune environments of CNK-UT009 cells.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
