Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I

Официальное название

Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression

Обзор

T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.

Подробное описание

One gene can be knockout of the T cells to produce a T-like NK cells which obtain killing function of both T effector cells and NK cells. We will collect appropriate patient's T cells, produce T-like NK cells (ITNK), and infuse the ITNK/CAR-ITNK cells back to the patients to treat various of cancers.

Вмешательства

• Биопрепарат ITNK cell therapy
  Infusion of ITNK/CAR-ITNK cells

Первичные конечные точки

• The safety and tolerance of the ITNK cell immunotherapy [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Percent of Patients with best response as either complete remission or partial remission. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Patients with advanced cancer, which express low or no MHC-I.
• Life expectancy >12 weeks
• Adequate heart,lung,liver,kidney function
• Available autologous T cells
• Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.

Критерии исключения

• Had accepted gene therapy before;
• Severe virus infection such as HBV,HCV,HIV,et al
• Known HIV positivity
• History of liver or other organ transplantation
• Active infectious disease related to bacteria, virus,fungi,et al
• Other severe diseases that the investigators consider not appropriate;
• Pregnant or lactating women
• Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
• Other conditions that the investigators consider not appropriate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Публикации

• Li P, Burke S, Wang J, Chen X, Ortiz M, Lee SC, Lu D, Campos L, Goulding D, Ng BL, Dougan G, Huntly B, Gottgens B, Jenkins NA, Copeland NG, Colucci F, Liu P. Reprogramming of T cells to natural killer-like cells upon Bcl11b deletion. Science. 2010 Jul 2;329(5987):85-9. doi: 10.1126/science.1188063. Epub 2010 Jun 10. PMID 20538915
• Jiang Z, Qin L, Tang Y, Liao R, Shi J, He B, Li S, Zheng D, Cui Y, Wu Q, Long Y, Yao Y, Wei Z, Hong Q, Wu Y, Mai Y, Gou S, Li X, Weinkove R, Norton S, Luo W, Feng W, Zhou H, Liu Q, Chen J, Lai L, Chen X, Pei D, Graf T, Liu X, Li Y, Liu P, Zhang Z, Li P. Human induced-T-to-natural killer cells have potent anti-tumour activities. Biomark Res. 2022 Mar 24;10(1):13. doi: 10.1186/s40364-022-00358-4. PMID 35331335

Идентификаторы

NCT: NCT03882840 · ZZITNK-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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