Refractory viral infection after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
trial group:CD45RA+ depleted adoptive cell therapy
Sponsors
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age between 1 to 18 years 2. BkV-associated grade II-IV HC or BKVemia or BKV nephropathy after allogeneic hematopoietic stem cell transplantation 3. Steroids (prednisone) usage of 0.5 mg/kg/day or less 4. Patients without grade III -IV acute GVHD or generalized chronic GVHD 5. Have suitable donor who can donate peripheral blood mononuclear cells 6. The patients' parents or guardians have the ability to understand and sign informed consent, willing and able to comply with the study of the program.
Exclusion criteria
Exclusion criteria: 1. Bacteria, fungi or parasites infection 2. Antithymocyte globulin, alenimumab, or other T cell monoclonal antibody were used within 4 weeks for transplant recipients 3.Patients experienced transplantation less than 28 days or received donor lymphocyte infusion within 28 days 4.Relapse of malignant tumor 5.Patient has contraindications to the investigational drug and excipients 6.Severe organ dysfunction:Left ventricular ejection fraction 3 times the upper limit of normal, serum alanine aminotransferase >10 times the upper limit of normal(Liver). 7.The estimated survival is over 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Response to infusion;aGVHD;Occurrence of nonhematologic SAEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of viremia;Changes in virus-specific T-cell levels; | — |
Countries
China
Contacts
Public ContactChengjuan Luo
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed