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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNK cells infusion patients | Experimental | Given iNK cell infusion after allo HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCR300(Allogenic Ipsc-derived Natural Killer cells ) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival time (DFS) | Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels | 1 year |
| complete remission rate (CR) | EBV-DNA negative rate in relapsed/non-remitting patients | 1 year |
| Recurrence rate (RT) | EBV-DNA reactivation rate for high-risk patients | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| cytomegalovirus DNA | Incidence of post-transplant infection-related comorbidities | 1 year |
| Adverse Event(AE) | Assess the frequency and extent of adverse events |
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Inclusion Criteria:
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;
â‘¢Abnormal phenotypic lymphocytes could still be detected in bone marrow immunotypingï¼›
â‘£Measurable EBV-related lesions on imagingï¼›
≤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 monthsï¼›
Agree to sign the Informed Consent Form。
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhao wang, MD | Contact | 86010631383803 | wangzhao@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D013577 | Syndrome |
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015616 | Histiocytosis, Non-Langerhans-Cell |
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|
| 1 year |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |