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Recruiting Phase 1 NCT03891706

Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors

Trial Parameters

Condition Solid Tumor
Sponsor Guangzhou FineImmune Biotechnology Co., LTD.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2019-01-08
Completion 2025-10-01
Interventions
tumor-specific TCR-T cellsInterleukin-2

Brief Summary

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 .

Eligibility Criteria

Inclusion Criteria: 1. Aged between 18 and 70 years old, regardless of gender; 2. Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated; 3. Be after standard treatment or who lack effective treatment programs; 4. Patients and their families were willing to participate in the clinical trial and signed the informed consent; 5. Physical status: ECOG score 0-1; 6. Expected survival time \> 3 months; 7. HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte \>0.8×10\^9/L, hemoglobin \>100g/L, and the pregnancy test of female patients with fertility potential was negative. 8. Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST \< 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin \< 3mg/dl except for Gilberts Syndrome; 9. At least 4 weeks after t

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