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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• maximum tolerant dose(MTD) [Срок оценки: 12 weeks after first injection]
• rate of DLT(dose-limiting toxicity) [Срок оценки: 12 weeks after first injection]

Вторичные конечные точки (3)

• adverse effects of CNK-UT009 [Срок оценки: 12 weeks]
• pharmacokinetics of CNK-UT009 [Срок оценки: 12 weeks]
• preliminary efficacy of CNK-UT009 [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07416383 · IR2025525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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