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

Recruiting now · Phase 1

Conditions studied: Nonsmall Cell Lung Cancer, Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT03778814

Run by

Second Affiliated Hospital of Guangzhou Medical University

People needed

30

Starts

2018-12-01

Expected to finish

2036-12-30

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. -

You may not qualify if…

• 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

• The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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