Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
Phase 1 · Testing injection of CNK-UT009 · Sites not listed yet · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing injection of CNK-UT009 (a drug) as a possible treatment. Condition(s) listed: Inflamatory Bowel Disease, Crohn Disease (CD) and Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-04-01 (planned).
- Main results expected around 2030-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- maximum tolerant dose(MTD) (12 weeks after first injection)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Inflamatory Bowel Disease; Crohn Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 40 (estimated) |
| Start date | 2026-04-01 |
| Primary completion (est.) | 2030-12-31 |
| First posted | 2026-02-18 |
| Last updated | 2026-02-18 |
| 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 |
| ClinicalTrials.gov ID | NCT07416383 |
Interventions
- 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 adve…
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.