New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.
This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy. TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen. The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors. The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors. Eligibility: Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
patients will be administration of TCR-T cells
Part of the non-myeloablative lymphocyte-depleting preparative regime
Part of the non-myeloablative lymphocyte-depleting preparative regime
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TCR-T cells therapy
Time frame: up to Day28
Adverse Event
The severity and incidence of various adverse events and serious adverse events
Time frame: up to 24 months
Overall response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) is observed as best overall response
Time frame: up to 24 months
Progression free survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first
Time frame: up to 24 months
Overall survival
OS defined as the time from start of treatment to the date of death due to any cause
Time frame: up to 24 months
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Part of the non-myeloablative lymphocyte-depleting preparative regime
Following cell infusion, the patient will be administration high-dose IL-2.