Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients

NCT07416383 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IR2025525
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Inflamatory Bowel Disease; Crohn Disease (CD); Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• adverse effects of CNK-UT009

  12 weeks

• pharmacokinetics of CNK-UT009

  12 weeks

• preliminary efficacy of CNK-UT009

  12 weeks

Other Outcomes (2)

• exploratory endpoint include long-term efficacy

  52 weeks after the first injection

• influence of immune environment

  12weeks and 52 weeks

Study Arms (1)

CNK-UT009 injection

EXPERIMENTAL

Drug: injection of CNK-UT009

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 adverse effects of our patients.

CNK-UT009 injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Yan Chen, Doctor

CONTACT

+86 13757118653; chenyan72_72@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share