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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Disease-free survival time (DFS)
Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
Time frame: 1 year
complete remission rate (CR)
EBV-DNA negative rate in relapsed/non-remitting patients
Time frame: 1 year
Recurrence rate (RT)
EBV-DNA reactivation rate for high-risk patients
Time frame: 1 year
cytomegalovirus DNA
Incidence of post-transplant infection-related comorbidities
Time frame: 1 year
Adverse Event(AE)
Assess the frequency and extent of adverse events
Time frame: 1 year
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