Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: injection of CNK-UT009.
- Who it may be relevant to
- Registry conditions: Inflamatory Bowel Disease, Crohn Disease (CD), Ulcerative Colitis (UC). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug injection 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.
Primary outcome measures
- maximum tolerant dose(MTD) [Time frame: 12 weeks after first injection]
- rate of DLT(dose-limiting toxicity) [Time frame: 12 weeks after first injection]
Secondary outcome measures (3)
- adverse effects of CNK-UT009 [Time frame: 12 weeks]
- pharmacokinetics of CNK-UT009 [Time frame: 12 weeks]
- preliminary efficacy of CNK-UT009 [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07416383 · IR2025525