NCT06491719

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome
• EBV
• Hemophagocytic Lymphohistiocytoses

Interventions

Type	Name	Description
OTHER	NCR300（Allogenic Ipsc-derived Natural Killer cells ）	Patients will receive iNK cells i.V. infusion at 1.0x10\^8/kg on days +14d, +21d, +28d, and +35d post-transplant. Continuation of the infusion after +35d post-transplant is at the discretion of the physician based on the patient's benefit.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-07-15
• Completion: 2026-07-15
• First posted: 2024-07-09
• Last updated: 2024-07-11

Locations

1 site across 1 country: China