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Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:
Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes (HS-IT101) for the Treatment of Advanced Breast Cancer

Clinical Trial Summary

Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced breast cancer.

Clinical Trial Description

HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with advanced breast cancer. The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide, followed by infusion of autologous TIL, then finnaly followed by the administration of a regimen of IL-2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05505812
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact Haibo Wang, MD
Phone 18661805787
Email hbwang66@126.com
Status Not yet recruiting
Phase Early Phase 1
Start date October 8, 2022
Completion date March 31, 2027
View Details
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