The purpose of this study is to optimize the traditional treatment scheme and explore the cure scheme for the elderly by combining the existing mature treatment technology. The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of MDS patients.
elderly MDS patients;
aged more than 60 years old, general condition, ECOG score less than 1;
normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L;
patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation;
serious infection was not controlled before treatment;
contraindications for the use of dexitabine and azacytidine;
other cases that did not meet the admission criteria.
Parallel
DC vaccine
Biological/VaccineEDC cell therapy collection and administration process. Collection of PBMC for preparation of DC cells for patients with autologous DC cells, patient PBMC was collected 10-16 weeks before administration for the preparation and large-scale culture of DC cells. For the patients with matched DC cells, a small amount of peripheral blood was taken for HLA typing 4 weeks before administration, and then the matched DC cells were cultured on a large scale.
OS
Overall survival
the Incidence of Treatment Adverse Events
The primary objective of this single-arm phase I clinical study is to determine the Incidence of Treatment Adverse Events in elder MDS or MDS/AML patients.
RR
Relapse rate
RFS
Relapse-free survival
Click on the lead sponsor to view all of their trials.
