TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Dec 16, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment called TCR-T cell immunotherapy for patients with advanced lung cancer or other solid tumors. The goal is to see if this therapy is safe, well-tolerated, and effective in fighting these cancers. Researchers will take a sample of the tumor from participants and grow special immune cells, which will be trained to recognize and attack the cancer cells. These trained cells will then be reintroduced into the patient's body through different methods, such as an injection into the vein or directly into the tumor.

To be eligible for this trial, participants need to have advanced lung cancer or another solid tumor that can be biopsied, and they should have a life expectancy of more than 12 weeks. Other key requirements include having functioning heart, lung, liver, and kidney health. Participants will need to provide informed consent, meaning they understand the study and agree to take part. This trial is currently recruiting participants aged 18 and older, and all genders are welcome. It's important to note that people with certain conditions, like severe infections or a history of specific therapies, may not be eligible. Overall, this study aims to explore a promising new way to help fight cancer using the body's own immune system.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable
• • 2. Life expectancy \>12 weeks
• • 3. Child-Pugh-Turcotte score \<7
• • 4. Adequate heart,lung,liver,kidney function
• • 5. Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay
• • 6. Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -
• Exclusion Criteria:
• • 1. Had accepted gene therapy before;
• • 2. Tumor size more than 25cm;
• • 3. Severe virus infection such as HBV, HCV, HIV, et al
• • 4. Known HIV positivity
• • 5. History of lung transplantation
• • 6. Active infectious disease related to bacteria, virus,fungi,et al
• • 7. Other severe diseases that the investigators consider not appropriate;
• • 8. Pregnant or lactating women
• • 9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
• • 10. Other conditions that the investigators consider not appropriate.