NCT06666153

Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study intends to conduct a prospective single-center open single-arm multi-dose escalation study on therapeutic immunological agent treatment in patients with Lymphoproliferative disease associated with EBV to observe the safety and efficacy.

Conditions

• CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome
• PTLDs

Interventions

Type	Name	Description
BIOLOGICAL	EBV immunological agent	27 participants with will be enrolled in the study and divided into three groups, including EBV-LPD (Adults group), EBV-LPD (Children group) and PTLD (Adults group） each with 9 people.The participants will be divided into three different dose groups, and a "3+3" dose escalation design is used. The low dose is 5.0×10\^5, the medium dose is 2.0×10\^6 and the high dose is 5.0×10\^6 for children and low dose is 5.0×10\^6, the medium dose is 2.0×10\^7 and the high dose is 5.0×10\^7 for adults. Only one dose will be administered to each participant with EBV immunological agent combined with Toripalimab 240mg.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: China