Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Soft Tissue Sarcoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adenovirus-transfected DC + CIK | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adenovirus-transfected DC + CIK
- description
- Adenovirus-transfected autologous DCs + CIK cells
- interventionNames
- Biological: Adenovirus-transfected DC + CIK
Primary outcomes (1)
- measure
- PFS/OS
- timeFrame
- 1 years after DC/CIK treatment
Secondary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 3 days within DC/CIK treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available