Crohn Disease (CD), Inflamatory Bowel Disease, Ulcerative Colitis (UC)
Conditions
Brief summary
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.
Interventions
DRUGinjection of CNK-UT009
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * welling to paticipate
Exclusion criteria
* 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 * patients with planned surgery in three months * unsuitable situations determined by researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of DLT(dose-limiting toxicity) | 12 weeks after first injection | indicate the safety |
| maximum tolerant dose(MTD) | 12 weeks after first injection | indicate the safty |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effects of CNK-UT009 | 12 weeks | rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect) |
| pharmacokinetics of CNK-UT009 | 12 weeks | take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009 |
| preliminary efficacy of CNK-UT009 | 12 weeks | rate of clinical remission patients after EOT-I(end of induction treatment phase), rate of endoscopic remission patients after EOT-I. |
Contacts
CONTACTYan Chen, Doctor
Outcome results
None listed