Inflamatory Bowel DiseasePhase 1NCT07416383
Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
A Phase 1 study testing injection of CNK-UT009 in people with Inflamatory Bowel Disease and Crohn Disease (CD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflamatory Bowel Disease, Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- injection of CNK-UT009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- injection of CNK-UT009
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of CNK-UT009Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| CNK-UT009 injection | Experimental | Not described Receives: Drug: injection of CNK-UT009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerant dose(MTD)
indicate the safty
Measured: 12 weeks after first injection
rate of DLT(dose-limiting toxicity)
indicate the safety
Measured: 12 weeks after first injection
Secondary outcomes (3)
adverse effects of CNK-UT009
rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect)
Measured: 12 weeks
pharmacokinetics of CNK-UT009
take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416383
- Sponsor's protocol ID
- IR2025525
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IR2025525
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNK-UT009 injection | Experimental | Drug: injection of CNK-UT009 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of CNK-UT009CNK-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. | Drug | CNK-UT009 injection |
Primary outcome
maximum tolerant dose(MTD)
Time frame: 12 weeks after first injection
indicate the safty
rate of DLT(dose-limiting toxicity)
Time frame: 12 weeks after first injection
indicate the safety
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Inflamatory Bowel Disease
Recruiting
Non-nutritive Sweeteners in Inflammatory Bowel Disease
Inflamatory Bowel Disease, Crohn Disease (CD)
Active, not recruiting
Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Inflamatory Bowel Disease
RecruitingObservational study
Inflammatory Bowel Disease (IBD) Research Registry
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
Not yet recruitingObservational study
Screening Questionnaires and Musculoskeletal Ultrasound for Early Detection of Spondyloarthritis in IBD Patients
Inflamatory Bowel Disease, Spondylarthritis
RecruitingObservational study
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
Inflamatory Bowel Disease, Crohn Disease (CD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing injection of CNK-UT009 in people with Inflamatory Bowel Disease and Crohn Disease (CD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Chen, Doctor (+86 13757118653, chenyan72_72@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerant dose(MTD) (time frame: 12 weeks after first injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.