NCT05616468

BGT007 Cell Treatment of Nasopharyngeal Carcinoma

Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Detailed description

The researchers designed a single arm, open, exploratory study to improve the "3+3" dose escalation. The maximum dose or the best effective dose shall be determined according to the subject and dose increasing test to verify the safe and effective number of cells per unit weight. The improved "3+3" dose increasing design was adopted, and BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 5.0 × 10\^5cells/kg，1.0 × 10\^6cells/kg，3.0 × 10\^6cells/kg，6.0 × 10\^6cells/kg，1.0 × 10\^7cells/kg。 Cell reinfusion will be carried out on day 0 (d0), and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period)

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	BGT007 Cell Injection	BGT007 cells (d0) were infused intravenously once, and the dose group was 5.0 × 10\^5cells/kg，1.0 × 10\^6cells/kg，3.0 × 10\^6cells/kg，6.0 × 10\^6cells/kg，1.0 × 10\^7cells/kg。
DRUG	Fludarabine	Fludarabine 25\~30mg/m2/d was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)
DRUG	cyclophosphamide	250\~350mg/m2/d cyclophosphamide was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)

Timeline

• Start date: 2022-12-30
• Primary completion: 2024-12-01
• Completion: 2025-12-31
• First posted: 2022-11-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: China