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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04320303
Other study ID # 2016PhB175-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 23, 2020
Est. completion date December 31, 2021

Study information

Verified date June 2021
Source Peking University People's Hospital
Contact Xiang-Yu Zhao
Phone 861088325949
Email zhao_xy@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective or even the only way to cure blood malignant diseases. Cytomegalovirus (CMV) infection is a serious early complication of allo-HSCT. Its high incidence and poor prognosis can cause a series of terminal organ diseases such as CMV pneumonia, encephalitis, and enteritis,which seriously affecting the prognosis of patients post allo-HSCT. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) or myeloma or lymphoma undergoing haploidentical allogeneic stem cell transplantation 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: 1. Participants in any other clinical trials within 1 month before enrollment 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.

Study Design


Intervention

Biological:
expanded NK cells
Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.

Locations

Country Name City State
China Peking University Institute of Hematology Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative incidence of CMV infection post transplantation Whether to reduce the incidence of CMV infection in patients post haploidentical transplantation within 180 days post transplantation
Secondary Cumulative incidence of refractory CMV infection post transplantation Whether to reduce the incidence of refractory CMV infection in patients post haploidentical transplantation within 180 days post transplantation
Secondary Cumulative incidence of CMV disease post transplantation Whether to reduce the incidence of CMV disease in patients post haploidentical transplantation within 180 days post transplantation
Secondary Enhanced anti-CMV function of reconstituted NK cells Whether to enhance the anti-CMV function of reconstituted NK cells within 180 days post transplantation
Secondary cumulative incidence of TRM Whether to reduce the incidence of transplantation related mortality in patients post haploidentical transplantation within 180 days post transplantation
Secondary cumulative incidence of overall survival Whether to increase the incidence of overall survival in patients post haploidentical transplantation within 180 days post transplantation
Secondary cumulative incidence of disease free survival Whether to increase the incidence of disease free survival in patients post haploidentical transplantation within 180 days post transplantation
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