NCT01898663
Recruiting
Phase 1
Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
Affiliated Hospital to Academy of Military Medical Sciences1 site in 1 country30 target enrollmentJune 2013
ConditionsHigh-risk Soft Tissue Sarcoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- High-risk Soft Tissue Sarcoma
- Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- PFS/OS
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
PFS/OS
Time Frame: 1 years after DC/CIK treatment
Secondary Outcomes
- Number of participants with adverse events(3 days within DC/CIK treatment)
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 1
DC Vaccine Combined With CIK Cells in Patients With Renal Cell CarcinomaRenal Cell CarcinomaNCT01924156Affiliated Hospital to Academy of Military Medical Sciences30
Unknown
Phase 1
Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone MetastasesNon-Small-Cell Lung Cancer With Bone MetastasesNCT02688686Affiliated Hospital to Academy of Military Medical Sciences30
Unknown
Phase 1
DC Vaccine Combined With CIK Cells in Patients With SCLCSmall- Cell Lung CancerNCT02688673Affiliated Hospital to Academy of Military Medical Sciences30
Completed
Phase 1
Autologous Dendritic Cell Vaccine in HIV1 InfectionHIV InfectionsNCT00510497Sharon Riddler11
Completed
Phase 1
Dendritic Cell Vaccine Study (DC/PC3) for Prostate CancerProstate CancerNCT00345293Rockefeller University13