New immunotherapy using T-like NK cells for cancer without MHC-I

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to develop a novel immunotherapy using T cell-like NK cells (ITNK) to treat advanced cancers that lack MHC-I molecule expression. The approach involves collecting patients' T cells, modifying them to enhance their cancer-fighting capabilities, and infusing these engineered cells back into the patients. The study is designed to evaluate the safety and efficacy of this therapy in a Phase 1 and Phase 2 setting, following successful pre-clinical investigations. The goal is to provide a new treatment option for patients with limited therapeutic targets.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD,PhD
• Email: zhangzhf@gzhmu.edu.cn
• Phone: +862034153532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.