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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNK-UT009 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of CNK-UT009 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerant dose(MTD) | indicate the safty | 12 weeks after first injection |
| rate of DLT(dose-limiting toxicity) | indicate the safety | 12 weeks after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects of CNK-UT009 | rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect) | 12 weeks |
| pharmacokinetics of CNK-UT009 | take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks after the first injection |
| influence of immune environment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Chen, Doctor | Contact | +86 13757118653 | chenyan72_72@zju.edu.cn |
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|
| 12 weeks |
| 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. | 12 weeks |
analyse immune cell components and levels of cytokines in blood samples to describe the influence on immune environments of CNK-UT009 cells.
| 12weeks and 52 weeks |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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