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NOT YET RECRUITING
NCT06666153
PHASE1

Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2024-10

Completion Date

2026-12

Last Updated

2024-10-30

Healthy Volunteers

No

Interventions

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.

Locations (1)

West China Hospital

Chengdu, Sichuan, China