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

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 Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD); Ulcerative Colitis (UC); Inflamatory Bowel Disease
• Intervention / Treatment: Drug: injection of CNK-UT009

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Chen, Doctor; Phone Number: +86 13757118653; Email: chenyan72_72@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CNK-UT009 injection

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: IR2025525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No