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

Capital Medical University

Status: Not yet enrolling

Conditions: EBV; Hemophagocytic Lymphohistiocytoses; CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome

Treatments: Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ）

Study type: Interventional

Funder types: Other

Identifiers

NCT06491719

2024-P2-053-02

Details and patient eligibility

About

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)

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

iNK cells infusion patients

Experimental group

Description:

Given iNK cell infusion after allo HSCT

Treatment:

Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ）