DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML
Phase 1
Recruiting
- Conditions
- High-risk Soft Tissue Sarcoma
- Interventions
- Biological: Adenovirus-transfected DC + CIK
- Registration Number
- NCT01898663
- Lead Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adenovirus-transfected DC + CIK Adenovirus-transfected DC + CIK Adenovirus-transfected autologous DCs + CIK cells
- Primary Outcome Measures
Name Time Method PFS/OS 1 years after DC/CIK treatment
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events 3 days within DC/CIK treatment
Trial Locations
- Locations (1)
Department of Hematopoietic Stem Cell Transplantation
🇨🇳Beijing, China