CMV Infection and Immune Intervention After Transplantation
NCT ID: NCT04320303
Last Updated: 2021-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-03-23
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Our data show that rapid reconstruction of NK cells after transplantation can reduce the incidence of CMV infection. Patients with a rapid reconstruction of NKG2C after transplantation have a low CMV infection rate, and patients with strong secretion of IFN-gamma of NK after transplantation have low CMV infection.
Our previous research showed that trophoblast cells transfected with IL-21 and 4-1BBL can achieve a large number of clinical-grade expansion of NK cells (mIL-21 / 4-1BBL NK cells), and mIL-21 / 4-1BBL NK cells It is safe to treat patients with minimal residual disease (MRD) positive AML after transplantation, and can induce MRD to turn negative. Previous studies have shown that adoptive infusion of expanded NK cells after haplotype transplantation is safe and can improve the functional reconstruction of NK cells. Therefore, we hypothesized that the infusion of NK cells can improve the antiviral capacity of NK cells, thereby effectively reducing the CMV infection. Incidence.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preemptive Therapy With CMV-specific T Cells Infusion to Prevent Refractory CMV Infection Post Transplantation
NCT02985775
Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies
NCT05656599
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
NCT05315882
Study of Adoptive Immunotherapy With Donor-derived CMV-specific T Cells for Recipients of Allo-HSCT
NCT02988258
Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT
NCT05075837
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
adaptive NK cells infusion post transplantation
Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation
expanded NK cells
Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
expanded NK cells
Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. No CMV infection by 20 days ± 3 days after transplantation
3. No active acute GVHD by 20 days ± 3 days after transplantation
4. The dose of prednisolone was less than 0.5mg / kg / d within 72 hours before and after infusion of NK cells
5. Prior to transplantation, the CMV IgG of the recipient and donor were positive, and the recipient had a suitable donor to expand NK cells.
6. Patient age 16-65 years
7. Donor age 16-65 years
8. Patient Karnofsky score\> 70%
9. Estimated survival\> 3 weeks
10. Patient agrees to participate in study
Exclusion Criteria
2. Active infection
3. HBV or HCV or HIV carriers
4. With moderate to severe renal dysfunction (blood creatinine\> 130umol / L) and / or liver dysfunction (total bilirubin\> 34umol / L, ALT, AST\> 2 times the upper limit of normal) before NK infusion
5. Researchers do not consider it appropriate to participate in this trial.
16 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaojun Huang,MD
President
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Institute of Hematology
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016PhB175-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.