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Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

NCT06666153 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-10-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666153 on ClinicalTrials.gov