Combining dendritic cell vaccines with killer cells for treating AML
Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
This study is testing a new treatment that combines a special vaccine with immune cells to see if it can help people with acute myeloid leukemia fight their cancer better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital to Academy of Military Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT01898663 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a dendritic cell (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients diagnosed with acute myeloid leukemia (AML). The DCs are engineered using a recombinant adenovirus to express specific tumor antigens, MUC1 and Survivin, to enhance the immune response against cancer cells. The study aims to build on promising preclinical results and assess the potential of this immunotherapy approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of AML and a Karnofsky Performance Scale score of 70 or higher.
Not a fit: Patients with serious organ dysfunction, other malignancies, or those currently participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients with AML, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar immunotherapy strategies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Department of Hematopoietic Stem Cell Transplantation — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Chen Hu, M.D., Ph.D. — Affiliated Hospital to Academy of Military Medical Sciences
- Study coordinator: Bin Zhang, M.D., Ph.D.
- Email: zb307ctc@163.com
- Phone: +86-010-6694-7125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.