TCR-T Cell for Immunotherapy of Lung Cancer and Other Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03778814|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nonsmall Cell Lung Cancer Solid Tumor, Adult||Biological: TCR-T cells||Phase 1|
- Choose appropriate patients with advanced lung cancer or other solid tumors, with written consent for this study;
- Perform biopsy to obtain tissue for organoids and TILs, coculture to screening anti-tumor T cells, select monoclonal T cells;
- Clone TCR sequence; collect PBMCs from the blood of the patients, isolate and activate the T cells and produce TCR-T cells;
- Test the quality and killing activity of the TCR-T cells and then transplant back the patients via systemic (vein and/or artery) or local injections, and follow up closely to collect related clinical data as needed;
- Evaluate the clinical results as needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: TCR-T cell therapy group
Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells.
Biological: TCR-T cells
Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.
- Number of Patients with Dose Limiting Toxicity [ 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.
- Percent of Patients with best response as either complete remission or partial remission [ 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.
- Median TCR-T cell persistence [ Time Frame: Five years ]Median TCR-T cell persistence will be measured by quantitative rt-PCR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778814
|Contact: Zhenfeng Zhang, MD,PhDemail@example.com|
|Contact: Liangping Li, MD,PhDfirstname.lastname@example.org|
|The Second Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guanzhou, Guangdong, China, 51260|
|Contact: Zhenfeng Zhang, MD,PhD 02034153532 email@example.com|
|Principal Investigator:||Zhenfeng Zhang, MD,PhD||Second Affiliated Hospital of Guangzhou Medical University|