CMV Infection and Immune Intervention After Transplantation

NCT04320303 | Unknown

• 1 other identifier: 2016PhB175-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

CMV Viremia; Transplantation Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulative incidence of refractory CMV infection post transplantation

  within 180 days post transplantation

• Cumulative incidence of CMV disease post transplantation

  within 180 days post transplantation

• Enhanced anti-CMV function of reconstituted NK cells

  within 180 days post transplantation

• cumulative incidence of TRM

  within 180 days post transplantation

• cumulative incidence of overall survival

  within 180 days post transplantation

Study Arms (1)

adaptive NK cells infusion post transplantation

EXPERIMENTAL

Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation

Biological: expanded NK cells

Interventions

expanded NK cells BIOLOGICAL

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

adaptive NK cells infusion post transplantation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) or myeloma or lymphoma undergoing haploidentical allogeneic stem cell transplantation
• No CMV infection by 20 days ± 3 days after transplantation
• No active acute GVHD by 20 days ± 3 days after transplantation
• The dose of prednisolone was less than 0.5mg / kg / d within 72 hours before and after infusion of NK cells
• Prior to transplantation, the CMV IgG of the recipient and donor were positive, and the recipient had a suitable donor to expand NK cells.
• Patient age 16-65 years
• Donor age 16-65 years
• Patient Karnofsky score\> 70%
• Estimated survival\> 3 weeks
• Patient agrees to participate in study

You may not qualify if:

• Participants in any other clinical trials within 1 month before enrollment
• Active infection
• HBV or HCV or HIV carriers
• 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
• Researchers do not consider it appropriate to participate in this trial.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

RECRUITING

Central Study Contacts

Xiang-Yu Zhao

CONTACT

861088325949; zhao_xy@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 24, 2020
• Study Start: March 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)