Clinical trial NCT06491719: A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome
EBV
Hemophagocytic Lymphohistiocytoses
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 15
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 relapse and EBV-DNA reactivation up to one year.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival time (DFS)
timeFrame: 1 year
measure: complete remission rate (CR)
timeFrame: 1 year
measure: Recurrence rate (RT)
timeFrame: 1 year
Secondary outcomes:
measure: cytomegalovirus DNA
timeFrame: 1 year
measure: Adverse Event（AE）
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References: