Status:
NOT_YET_RECRUITING
A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome
EBV
Eligibility:
All Genders
Up to 65 years
Phase:
NA
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 all...
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 ongoin...
Eligibility Criteria
Inclusion
- 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；
- ≤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；
- Agree to sign the Informed Consent Form。
Exclusion
- 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.)；
- Also participation in other interventional clinical studies within 4 weeks
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06491719
Start Date
July 15 2024
End Date
July 15 2026
Last Update
July 11 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China