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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adaptive NK cells infusion post transplantation | Experimental | Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| expanded NK cells | Biological | Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative incidence of CMV disease post transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang-Yu Zhao | Contact | 861088325949 | zhao_xy@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Institute of Hematology | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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Whether to reduce the incidence of CMV disease in patients post haploidentical transplantation |
| within 180 days post transplantation |
| Enhanced anti-CMV function of reconstituted NK cells | Whether to enhance the anti-CMV function of reconstituted NK cells | within 180 days post transplantation |
| cumulative incidence of TRM | Whether to reduce the incidence of transplantation related mortality in patients post haploidentical transplantation | within 180 days post transplantation |
| cumulative incidence of overall survival | Whether to increase the incidence of overall survival in patients post haploidentical transplantation | within 180 days post transplantation |
| 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 |