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| Name | Class |
|---|---|
| Sun Yat-Sen University Cancer Center | OTHER |
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The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .
The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .
This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCR-T cell infusion | Experimental | Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tumor-specific TCR-T cells | Drug | On day 0 and day 14, 0.5-5x10^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | Keep records the adverse events experienced by subjects in 30 days after the last infusion. | At least 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST | one year |
| overall survival(OS) | The time from the first injection of Investigational Product until death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuzhi Pan | Contact | 86-20-87343135 | panxzh@sysucc.org.cn | |
| Haiping Liu | Contact | 020-31605836 | liuhp11@fineimmu.com |
| Name | Affiliation | Role |
|---|---|---|
| Penghui Zhou | Guangzhou FineImmune Biotechnology Co., LTD. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Gaungdong | 510700 | China |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Interleukin-2 | Drug | Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days . |
|
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| two year |
| progression-free survival(PFS) | PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST | two year |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |