Clinical trial NCT04320303: CMV Infection and Immune Intervention After Transplantation
Official title: CMV Infection and Immune Intervention After Haploidentical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CMV Viremia
Transplantation Infection
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of CMV infection post transplantation
timeFrame: within 180 days post transplantation
Secondary outcomes:
measure: Cumulative incidence of refractory CMV infection post transplantation
timeFrame: within 180 days post transplantation
measure: Cumulative incidence of CMV disease post transplantation
timeFrame: within 180 days post transplantation
measure: Enhanced anti-CMV function of reconstituted NK cells
timeFrame: within 180 days post transplantation
measure: cumulative incidence of TRM
timeFrame: within 180 days post transplantation
measure: cumulative incidence of overall survival
timeFrame: within 180 days post transplantation
measure: cumulative incidence of disease free survival
timeFrame: within 180 days post transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
References: