Actively Recruiting
DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML
Led by Affiliated Hospital to Academy of Military Medical Sciences · Updated on 2024-07-01
30
Participants Needed
1
Research Sites
604 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis consistent with acute myeloid leukemia (AML)
- Age 18 years or older at the time of consent
- Karnofsky Performance Scale (KPS) score of 70 or higher
- Written informed consent provided
- No steroid therapy within 4 weeks before first DC vaccination
- Disease status stable, complete response, or partial response by WHO or RECIST criteria
- Predicted survival of 3 months or more
You will not qualify if you...
- Serious dysfunction of vital organs such as heart, liver, or kidney
- History of organ transplantation
- Presence of other malignancies or brain metastases
- History of autoimmune diseases
- Pregnant or breastfeeding
- Active or chronic infectious diseases
- History of allergy or hypersensitivity to study product ingredients
- Currently participating in another clinical trial
- Received chemotherapy, radiotherapy, immune inhibitors (like corticosteroids), or other immunotherapy (such as vaccines) within 4 weeks prior
- Considered unfit for participation by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Hematopoietic Stem Cell Transplantation
Beijing, China, 100071
Actively Recruiting
Research Team
B
Bin Zhang, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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