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| Name | Class |
|---|---|
| Tcell Immune (Guangzhou) Science and Technology Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCR-T cell therapy group | Experimental | Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCR-T cells | Biological | Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dose Limiting Toxicity | 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. | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients with best response as either complete remission or partial remission | 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. | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Median TCR-T cell persistence | Median TCR-T cell persistence will be measured by quantitative rt-PCR. | Five years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD,PhD | Contact | 0086-020-34153532 | zhangzhf@gzhmu.edu.cn | |
| Liangping Li, MD,PhD | Contact | 020-38688609 | liangping_li@jnu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD,PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guanzhou | Guangdong | 51260 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |