DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML

Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study

The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Inclusion Criteria:

• Consistent with the diagnosis of AML
• Age≥18 years at time of consent
• KPS(Karnofsky Performance Scale) ≥70
• Patient's written informed consent
• No steroid therapy within 4 weeks of first DC vaccination
• Stable disease, complete response and partial response(WHO, RECIST)
• Predicted survival≥3 months

Exclusion Criteria:

• Serious dysfunction of vital organs(heart, liver or kidney)
• Received organ transplantation
• Patients with other malignancies or brain metastases
• History of autoimmune diseases
• Pregnant and breast-feeding patient
• Active or chronic infectious diseases
• History of allergy or hypersensitivity to study product excipients
• Currently participating in another clinical trial
• Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
• Unfit for participating in this clinical trial in investigators' opinions