Vakcinace pacientů s mnohočetným myelomem dendritickými buňkami naloženými monoklonálním imunoglobulinem – první výsledky klinické studie fáze II.
| Title in English | The use of dendritic cells loaded with monoclonal immunoglobulin for the vaccination of myeloma patients: preclinical and first clinical results of a phase I/II clinical trial. |
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| Authors | |
| Year of publication | 2008 |
| Type | Conference abstract |
| MU Faculty or unit | |
| Citation | |
| Description | 6 patients with multiple myeloma not requiring systemic therapy was enrolled to the study. Patients received 6 doses of dendtitic cells (DCs) loaded with autologous Id-protein every 4 weeks. The vaccine was administered subcutaneously. Autologous mature DCs derived from peripherial blood monocytes were prepared in vitro and loaded with Id-protein under the GMP conditions. The vaccine was administrated after safety and quality evaluation. A clinical response was evaluated by measuring the monoclonal immunoglobulin levels in peripheral blood. An immune response was monitored by flow cytometry every 4 weeks as well as the production of interferon gamma (evaluated by Elispot) by myeloma-reactive T lymphocytes. A delayed type hypersensitivity test was performed every 3 months. 36 vaccines which fulfiled the conditions were preparated and administered. Vaccination was well tolerated, no significant grade II-IV toxicities were observed. A local reaction (erythema or induration) was observed in all patients and disappeared in few days. The immune response to the vaccine was noticed in 5 of 6 patients. 5 patients remained in stable disease while one revealed progressive disease. Vaccination with Id-protein loaded autologous DCs is a safe therapeutic strategy with no significant side effects. The trial is ongoing and a total number of 12 patients is planned to be enrolled. |
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