CMV Infection and Immune Intervention After Transplantation

Transplantation Infection Clinical Trial

Official title:

CMV Infection and Immune Intervention After Haploidentical Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320303
• Other study ID #: 2016PhB175-01
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• CMV Viremia
• Communicable Diseases
• Cytomegalovirus Infections
• Infection
• Transplantation Infection
• Viremia

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