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Updated: Mar 7, 2026
Preparation of Tumor Antigen-loaded Mature Dendritic Cells for Immunotherapy
Published on: August 1, 2013
Phase 1/2 study of immunotherapy with dendritic cells pulsed with autologous tumor lysate in patients with refractory
Shinji Miwa1, Hideji Nishida1, Yoshikazu Tanzawa1
1Department of Orthopedic Surgery, Kanazawa University School of Medicine, Kanazawa, Japan.
Background:
There are limited options for the curative treatment of refractory bone and soft tissue sarcomas. The purpose of this phase 1/2 study was to assess the immunological and clinical effects of dendritic cells (DCs) pulsed with autologous tumor lysate (TL) in patients with advanced bone and soft tissue sarcomas.
Methods:
Thirty-seven patients with metastatic or recurrent sarcomas were enrolled in this study. Peripheral blood mononuclear cells obtained from the patients were suspended in media containing interleukin 4 (IL-4) and granulocyte-macrophage colony-stimulating factor. Subsequently, these cells were treated with TL, tumor necrosis factor α, and OK-432. The DCs were injected into the inguinal or axillary region. One treatment course comprised 6 weekly DC injections. The toxicity, clinical response (tumor volume, serum interferon-γ [IFN-γ], and serum IL-12), and oncological outcomes were observed.
Results:
In total, 47 courses of DC therapy were performed in 37 patients. No severe adverse events or deaths associated with the DC injections were observed in the study patients. Increased serum IFN-γ and IL-12 levels were observed 1 month after the DC injection. Among the 37 patients, 35 patients were assessed for clinical responses: 28 patients showed tumor progression, 6 patients had stable disease, and 1 patient showed a partial response 8 weeks after the DC injection. The 3-year overall and progression-free survival rates of the patients were 42.3% and 2.9%, respectively.
Conclusions:
Although DC therapy appears safe and resulted in an immunological response in patients with refractory sarcoma, it resulted in an improvement of the clinical outcome in only a small number of patients. Cancer 2017;123:1576-1584. © 2017 American Cancer Society.
Insights
Dendritic cell (DC) therapy pulsed with tumor lysate (TL) showed safety and induced an immune response in refractory sarcoma patients. However, clinical benefits were limited, with only one partial response observed.
Area of Science:
- Immunology
- Oncology
- Cell Therapy
Background:
- Limited curative treatment options exist for refractory bone and soft tissue sarcomas.
- Advanced sarcomas present a significant unmet medical need.
Purpose of the Study:
- To evaluate the immunological and clinical effects of dendritic cells (DCs) pulsed with autologous tumor lysate (TL).
- To assess the safety and efficacy of this novel immunotherapy in patients with advanced sarcomas.
Main Methods:
- Phase 1/2 study involving 37 patients with metastatic or recurrent sarcomas.
- Autologous peripheral blood mononuclear cells were cultured and pulsed with tumor lysate (TL).
- Dendritic cells (DCs) were administered weekly for 6 weeks, with toxicity and clinical response monitored.
Main Results:
- Dendritic cell (DC) therapy was well-tolerated, with no severe adverse events.
- Increased serum levels of interferon-gamma (IFN-γ) and interleukin-12 (IL-12) were observed post-treatment.
- One patient achieved a partial response, while 6 had stable disease; 28 showed progression.
Conclusions:
- Dendritic cell (DC) therapy is safe and elicits an immunological response in refractory sarcoma patients.
- The clinical benefit observed was limited, suggesting further research is needed to optimize outcomes.
