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

RecruitingPhase 1Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical U…
NCT03778814 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tumor organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.

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📋 Eligibility rules (as published)
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.
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What it tests

  • TCR-T cells
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Where

1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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