NCT06496724

A Clinical Study of Albumin-bound Paclitaxel/Granulocyte-based Therapy for Recurrent/Metastatic Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: JIANG LONGWEI · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Albumin-bound Paclitaxel/Granulocyte drug can treat patients with recurrent/metastatic breast cancer. The main questions it aims to answer are: To verify the safety of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer. To evaluate the efficacy of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer. To detect the pharmacokinetic behavior of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

Detailed description

In this open, single-armed study, selected patients with recurrent/metastatic breast cancer confirmed by Histopathology will be received Albumin-bound Paclitaxel/Granulocyte-based therapy. The granulocyte will be separated by blood cell separator, and will be cultured in the GMP laboratory to make Albumin-bound Paclitaxel/Granulocyte drug. Then the drug will be infused intravenous into patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Albumin paclitaxel/neutrophil drug	Isolate the patients' autologous neutriphil cells, induce and culture them with albumin paclitaxel in vitro. The final product for Albumin paclitaxel/neutrophil drug.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-30
• Completion: 2025-07-01
• First posted: 2024-07-11
• Last updated: 2025-02-12

Locations

2 sites across 1 country: China