NCT03891706

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

An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.
DRUG	Interleukin-2	Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .

Timeline

• Start date: 2019-01-08
• Primary completion: 2025-10-01
• Completion: 2025-12-31
• First posted: 2019-03-27
• Last updated: 2024-09-19

Locations

1 site across 1 country: China