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

Recruiting
18 years of age
Both
Phase 1/2

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Overview

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 cell therapy and scheduled to start a clinical phase I study.

Description

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 cells back to the patients to treat various of cancers.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details

Anti-cancer Cell Immunotherapy, T Cell and NK Cell

NCT03882840

Second Affiliated Hospital of Guangzhou Medical University

27 January 2024

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