NCT05654077

EBV CAR-T Cells for Nasopharyngeal Carcinoma

To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC

Detailed description

The investigators designed a single-arm, open-label, "3+3" dose-escalation exploratory study. According to the subject and dose escalation test, the maximum dose or the best effective dose was determined to verify the safe and effective number of cells per body weight. A "3+3" dose escalation design was used to set three dose groups of gradually increasing CAR-T cells for therapeutic evaluation. The dose groups were 3.0×10\^6cells/kg, 9.0×10\^6cells/kg and 1.5×10\^7cells/kg, respectively. Cell reinfusion will take place 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	CAR-T Cell Injection	intravenously once, and the dose group was 3.0 × 10\^6cells/kg、9.0 × 10\^6cells/kg、1.5 × 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: 2022-01-18
• Primary completion: 2022-12-30
• Completion: 2025-12-30
• First posted: 2022-12-16
• Last updated: 2022-12-19

Locations

1 site across 1 country: China