TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors
Recruiting · NCT03778814 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- patients with advanced lung tumor or other solid tumor where biopsy is obtainable
- Life expectancy \>12 weeks
- Child-Pugh-Turcotte score \<7
- Adequate heart,lung,liver,kidney function
- 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
- Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -
Exclusion criteria
- Had accepted gene therapy before;
- Tumor size more than 25cm;
- Severe virus infection such as HBV, HCV, HIV, et al
- Known HIV positivity
- History of lung 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.
Where it is running
1 location listed.
- The Second Affiliated Hospital of Guangzhou Medical University - Guanzhou, Guangdong, China