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

Not Applicable

Not yet recruiting

• Conditions: CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome; EBV; Hemophagocytic Lymphohistiocytoses
• Interventions: Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ）

• Registration Number: NCT06491719
• Lead Sponsor: Beijing Friendship Hospital

Brief 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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11
• Study Start: 2024-07-15
• Primary Completion: 2025-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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。

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iNK cells infusion patients	NCR300（Allogenic Ipsc-derived Natural Killer cells ）	Given iNK cell infusion after allo HSCT

Primary Outcome Measures

Name	Time	Method
Recurrence rate (RT)	1 year	EBV-DNA reactivation rate for high-risk patients
Disease-free survival time (DFS)	1 year	Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
complete remission rate (CR)	1 year	EBV-DNA negative rate in relapsed/non-remitting patients

Secondary Outcome Measures

Name	Time	Method
Adverse Event（AE）	1 year	Assess the frequency and extent of adverse events
cytomegalovirus DNA	1 year	Incidence of post-transplant infection-related comorbidities

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China