Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03891706|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 12, 2020
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 .
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: tumor-specific TCR-T cells Drug: Interleukin-2 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: TCR-T cell infusion
Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy
Drug: tumor-specific TCR-T cells
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.
Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .
Other Name: IL-2
Fludarabine 25mg/m2/ d.iv. -d4~ -d3 before the first cell infusion.
Other Name: Fludara
Cyclophosphamide 500mg/m2/ d.iv. -d4~ -d3 before the first cell infusion.
Other Name: Cytoxan
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: At least 45 days ]Keep records the adverse events experienced by subjects in 30 days after the last infusion.
- Disease Control Rate(DCR) [ Time Frame: one year ]DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST
- overall survival(OS) [ Time Frame: two year ]The time from the first injection of Investigational Product until death
- progression-free survival(PFS) [ Time Frame: two year ]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
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): NCT03891706
|Contact: Xuzhi Panemail@example.com|
|Contact: Haiping Liufirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Gaungdong, China, 510700|
|Contact: Xuzhi Pan 86-20-87343135 email@example.com|
|Principal Investigator: Xiaoshi Zhang, professor|
|Study Director:||Penghui Zhou||Guangzhou FineImmune Biotechnology Co., LTD.|