NCT07416383Not yet recruitingPhase 1
Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Nov 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07416383
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 1 Apr 2026 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with drug combination other than low-dose glucocotiod
- patients recieved abdominal surgery or live vaccine
- patients with planned surgery in three months
Other illness
- patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)
Other
- patients paticipated other clinical trials with four weeks
- unsuitable situations determined by researchers
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.