Vakcinace pacientů s mnohočetným myelomem dendritickými buňkami naloženými monoklonálním imunoglobulinem – první výsledky klinické studie fáze II.

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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.
Authors

ZAHRADOVÁ Lenka OČADLÍKOVÁ Darina KOVÁŘOVÁ Lucie SMEJKALOVÁ Jana POUR Luděk VIDLÁKOVÁ Petra KYJOVSKÁ Drahomíra MORAVCOVÁ Jana RYCOVÁ Marcela NOVOTNÁ Hana JELÍNKOVÁ Ivana PENKA Miroslav MICHÁLEK Jaroslav HÁJEK Roman

Year of publication 2008
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

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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