CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome, EBV, Hemophagocytic Lymphohistiocytoses
Conditions
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.
Interventions
OTHERNCR300（Allogenic Ipsc-derived Natural Killer cells ）
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.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Recurrence rate (RT) | 1 year | EBV-DNA reactivation rate for high-risk patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cytomegalovirus DNA | 1 year | Incidence of post-transplant infection-related comorbidities |
| Adverse Event（AE） | 1 year | Assess the frequency and extent of adverse events |
Countries
China
Contacts
Primary Contactzhao wang, MD
Outcome results
None listed