CAEBV (Chronic Active Epstein-Barr Virus Infection) SyndromeNCT06491719
A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT
A study testing NCR300（Allogenic Ipsc-derived Natural Killer cells ） in people with CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome and EBV, run by Beijing Friendship Hospital at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome, EBV, Hemophagocytic Lymphohistiocytoses
- What is being tested?
- NCR300（Allogenic Ipsc-derived Natural Killer cells ）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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。；
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- 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。
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Efficacy and Safety of iNK Cell Infusion in Patients With Chronic Active Epstein-Barr Virus Infection (CAEBV) and Epstein Barr Virus-induced Haemophagocytic Lymphohistiocytosis (EBV-HLH) After Allogeneic Hematopoietic Stem Cell Transplantation
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)
Read the 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.
- Conditions
- CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome, EBV, Hemophagocytic Lymphohistiocytoses
- Being tested
- NCR300（Allogenic Ipsc-derived Natural Killer cells ）
- Medical subject headings
- Syndrome, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| iNK cells infusion patients | Experimental | Given iNK cell infusion after allo HSCT Receives: Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time (DFS)
Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
Measured: 1 year
complete remission rate (CR)
EBV-DNA negative rate in relapsed/non-remitting patients
Measured: 1 year
Recurrence rate (RT)
EBV-DNA reactivation rate for high-risk patients
Measured: 1 year
Secondary outcomes (2)
cytomegalovirus DNA
Incidence of post-transplant infection-related comorbidities
Measured: 1 year
Adverse Event（AE）
Assess the frequency and extent of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAEBV (Chronic Active Epstein-Barr Virus Infection) SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491719
- Sponsor's protocol ID
- 2024-P2-053-02
- Status last verified
- Jun 2024
- First submitted
- 1 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Efficacy and Safety of iNK Cell Infusion in Patients With Chronic Active Epstein-Barr Virus Infection (CAEBV) and Epstein Barr Virus-induced Haemophagocytic Lymphohistiocytosis (EBV-HLH) After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06491719
- Acronym / sponsor ID
- 2024-P2-053-02
- Conditions
- CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome, EBV, Hemophagocytic Lymphohistiocytoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNK cells infusion patients | Experimental | Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ）Given iNK cell infusion after allo HSCT |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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；
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCR300（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. | Other | iNK cells infusion patients |
Primary outcome
Disease-free survival time (DFS)
Time frame: 1 year
Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels
complete remission rate (CR)
Time frame: 1 year
EBV-DNA negative rate in relapsed/non-remitting patients
Recurrence rate (RT)
Time frame: 1 year
EBV-DNA reactivation rate for high-risk patients
2 secondary outcomes
cytomegalovirus DNA
Time frame: 1 year
Adverse Event（AE）
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NCR300（Allogenic Ipsc-derived Natural Killer cells ） in people with CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome and EBV, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhao wang, MD (86010631383803, wangzhao@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (DFS) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.