About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≤65 years,ECOG :0-2;
Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase(ALT/AST)<200U/L。;
In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required;
Estimated survival time is longer than three months;
Disqualifiers
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;
Active infections other than EBV that have not yet been controlled;
Positive for hepatitis B virus or hepatitis C virus;
Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
Trial design
Single group
Treatments tested in this trial
NCR300(Allogenic Ipsc-derived Natural Killer cells )
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Disease-free survival time (DFS)
Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
complete remission rate (CR)
EBV-DNA negative rate in relapsed/non-remitting patients
Recurrence rate (RT)
EBV-DNA reactivation rate for high-risk patients
Secondary outcomes
cytomegalovirus DNA
Incidence of post-transplant infection-related comorbidities
Adverse Event(AE)
Assess the frequency and extent of adverse events
Sponsors and contacts
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