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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJuly 1, 2024
June 1, 2024
11.6 years
July 9, 2013
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
PFS/OS
1 years after DC/CIK treatment
Secondary Outcomes (1)
Number of participants with adverse events
3 days within DC/CIK treatment
Study Arms (1)
Adenovirus-transfected DC + CIK
EXPERIMENTALAdenovirus-transfected autologous DCs + CIK cells
Interventions
Adenovirus-transfected autologous DC vaccine plus CIK cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematopoietic Stem Cell Transplantation
Beijing, 100071, China
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Hu, M.D., Ph.D.
Affiliated Hospital to Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
June 1, 2013
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
July 1, 2024
Record last verified: 2024-06