To hear about similar clinical trials, please enter your email below
Trial Title:
A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT
NCT ID:
NCT06491719
Condition:
CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome
EBV
Hemophagocytic Lymphohistiocytoses
Conditions: Official terms:
Infections
Virus Diseases
Epstein-Barr Virus Infections
Lymphohistiocytosis, Hemophagocytic
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
NCR300（Allogenic Ipsc-derived Natural Killer cells ）
Description:
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.
Arm group label:
iNK cells infusion patients
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Start date:
July 15, 2024
Completion date:
July 15, 2026
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491719
