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New treatment option for Nonsmall Cell Lung Cancer
Official title TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT03778814
What this study is testing
What is TCR-T cells?
TCR-T cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for nonsmall cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
You likely can't join 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
See the full eligibility 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. -
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guanzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.