The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 51260, China
Location status: Recruiting
NCT Number: NCT03778814
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Guanzhou, Guangdong, 51260, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.
Time frame: three months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the TCR-T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Time frame: three months
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Time frame: Five years
Median TCR-T cell persistence will be measured by quantitative rt-PCR.
Contact information is provided by the study sponsor or research team.
Liangping Li, MD,PhD
CONTACT
Zhenfeng Zhang, MD,PhD
CONTACT
Second Affiliated Hospital of Guangzhou Medical University
Other
TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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