CI

At a glance

ClinicalIndex Comparison Record
Phase 1Not Yet Recruiting· 27 target
Drug / intervention
EBV immunological agentbiological
Likely dose
EBV immunological agent 240mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06666153
NCT06666153Phase 1Not Yet Recruiting
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A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

West China Hospital·interventional·Posted Oct 30, 2024·Updated Oct 30, 2024

In Brief

A Phase 1 clinical trial evaluating EBV immunological agent for CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome and PTLDs. Not yet recruiting, targeting 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome, PTLDs
CountriesChina
Collaborators--

Timeline

Phase 1Not Yet Recruiting
202520262027
First PostedOct 30, 2024
Enrollment StartOct 1, 2024
Primary CompletionDec 1, 2025
Study CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 1.7 years ago

Interventions

EBV immunological agentbiological

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.