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

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Mar 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new type of cancer treatment called Induced T Cell Like NK Cellular Immunotherapy. It aims to help patients with advanced cancers that do not have certain proteins (called MHC-I molecules) that are often targeted by traditional therapies. The researchers have developed a technique to create special immune cells from the patient’s own T cells, which can fight these hard-to-treat cancers. This study is currently looking for participants to enroll and is in the early Phase 1 stage, which means they are testing the treatment's safety and effectiveness.

To be eligible for the trial, patients must have advanced cancer with low or no MHC-I expression, a life expectancy of at least 12 weeks, and healthy heart, lung, liver, and kidney functions. They also need to have their own T cells available for use. However, certain individuals, such as those who have had previous gene therapy, are currently pregnant, or have severe infections, may not qualify. Participants in this trial can expect close monitoring and care from the medical team as they explore this innovative treatment option.

Gender

ALL

Eligibility criteria

• 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.