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NCT Number: NCT03882840

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location status: Recruiting

Location contact

Peng Li, PhD

SUB_INVESTIGATOR

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

+86-020-34153532

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ITNK cell therapy

Biological

Infusion of ITNK/CAR-ITNK cells

Primary outcomes

  1. The safety and tolerance of the ITNK cell immunotherapy

    Time frame: 2 years

    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ITNK cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. Incidence of treatment-emergent adverse events will be calculated as standard methods.

Secondary outcomes

  1. Percent of Patients with best response as either complete remission or partial remission.

    Time frame: 2 years

    Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Li, PhD

CONTACT

[email protected]

Zhenfeng Zhang, MD,PhD

CONTACT

[email protected]

+862034153532

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2035
First posted
Mar 20, 2019
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.