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

Phase 1Not Yet RecruitingNCT07416383

Second Affiliated Hospital, School of Medicine, Zhejiang University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

maximum tolerant dose(MTD)

indicate the safty

Time frame: 12 weeks after first injection

rate of DLT(dose-limiting toxicity)

indicate the safety

Time frame: 12 weeks after first injection

Secondary Outcomes

adverse effects of CNK-UT009

rate of TRAE(treatment related adverse effect), rate of TEAE(treatment emergent adverse effect)

Time frame: 12 weeks

pharmacokinetics of CNK-UT009

take blood samples to analyse the CNK-UT009 cell counts and draft the pharmacokinetics of CNK-UT009

Time frame: 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.

Time frame: 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts