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A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT | Clinical Trials | Clareo Health

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A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT

A Study on Efficacy and Safety of iNK Cell Infusion in Patients With Chronic Active Epstein-Barr Virus Infection (CAEBV) and Epstein Barr Virus-induced Haemophagocytic Lymphohistiocytosis (EBV-HLH) After Allogeneic Hematopoietic Stem Cell Transplantation

NCT06491719•Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of iNK cells infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Detailed Description

It is a prospective, open-lable study to evaluate the efficacy and safety of iNK cell infusion in CAEBV/EBV-HLH patients after allo-HSCT. The study will enroll fifteen subjects who will receive ongoing least 4 doses of iNK cells intravenously infusion after allogeneic hematopoietic stem cell transplantation. All subjects will assess the incidence of disease relapse and EBV-DNA reactivation up to one year.

Eligibility

Age

0 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with CAEBV or EBV-HLH who are eligible for allogeneic hematopoietic stem cell transplantation meet one of the following criteria:
•①EBV-DNA (PBMC or plasma) was still more than 103 before transplantation；②Positive for Cerebrospinal fluid EBV-DNA；
•③Abnormal phenotypic lymphocytes could still be detected in bone marrow immunotyping；
•④Measurable EBV-related lesions on imaging；
•2. ≤65 years，ECOG :0-2；
•3. Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase（ALT/AST）\<200U/L。；
•4. In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required；
•5. Estimated survival time is longer than three months；
•6. Agree to sign the Informed Consent Form。

Exclusion Criteria

•1. Patients with evidence of grade II or more serious heart disease according to the New York Heart Association (NYHA) score (including Grade II) ; Clear diagnosis of cirrhosis；
•2. Active infections other than EBV that have not yet been controlled；
•3. Positive for hepatitis B virus or hepatitis C virus；
•4. Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)；
•5. Also participation in other interventional clinical studies within 4 weeks

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

July 15, 2024

Primary Completion Date

July 15, 2025

Completion Date

July 15, 2026

Last Updated

July 11, 2024

Enrollment

ESTIMATED participants

Conditions

CAEBV (Chronic Active Epstein-Barr Virus Infection) SyndromeEBVHemophagocytic Lymphohistiocytoses

Interventions

NCR300（Allogenic Ipsc-derived Natural Killer cells ）

OTHER

Contacts

zhao wang, MD

CONTACT

86010631383803 wangzhao@ccmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT

Inclusion Criteria

Exclusion Criteria

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