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1. Adjuvant dendritic cell therapy in stage IIIB/C melanoma: the MIND-DC randomized phase III trial

Author

Bol, Kalijn F., Schreibelt, Gerty, Bloemendal, Martine, van Willigen, Wouter W., Hins-de Bree, Simone, de Goede, Anna L., de Boer, Annemiek J., Bos, Kevin J. H., Duiveman-de Boer, Tjitske, Olde Nordkamp, Michel A. M., van Oorschot, Tom G. M., Popelier, Carlijn J., Pots, Jeanne M., Scharenborg, Nicole M., van de Rakt, Mandy W. M. M., de Ruiter, Valeska, van Meeteren, Wilmy S., van Rossum, Michelle M., Croockewit, Sandra J., Koeneman, Bouke J., Creemers, Jeroen H. A., Wortel, Inge M. N., Angerer, Caroline, Brüning, Mareke, Petry, Katja, Dzionek, Andrzej, van der Veldt, Astrid A., van Grünhagen, Dirk J., Werner, Johanna E. M., Bonenkamp, Johannes J., Haanen, John B. A. G., Boers-Sonderen, Marye J., Koornstra, Rutger H. T., Boomsma, Martijn F., Aarntzen, Erik H. J., Gotthardt, Martin, Nagarajah, James, de Witte, Theo J. M., Figdor, Carl G., de Wilt, Johannes H. W., Textor, Johannes, de Groot, Jan Willem B., Gerritsen, Winald R., and de Vries, I. Jolanda M.

Published
2024
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2. Fully closed and automated enrichment of primary blood dendritic cells for cancer immunotherapy

Author

Schreibelt, Gerty, primary, Duiveman-de Boer, Tjitske, additional, Pots, Jeanette M., additional, van Oorschot, Tom G.M., additional, de Boer, Annemiek J., additional, Scharenborg, Nicole M., additional, van de Rakt, Mandy W.M.M., additional, Bos, Kevin, additional, de Goede, Anna L., additional, Petry, Katja, additional, Brüning, Mareke, additional, Angerer, Caroline, additional, Schöggl, Carola, additional, Dzionek, Andreas, additional, and de Vries, I. Jolanda M., additional

Published
2023
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3. Adjuvant dendritic cell therapy in stage IIIB/C melanoma:the MIND-DC randomized phase III trial

Author

Bol, Kalijn F., Schreibelt, Gerty, Bloemendal, Martine, van Willigen, Wouter W., Hins-de Bree, Simone, de Goede, Anna L., de Boer, Annemiek J., Bos, Kevin J.H., Duiveman-de Boer, Tjitske, Olde Nordkamp, Michel A.M., van Oorschot, Tom G.M., Popelier, Carlijn J., Pots, Jeanne M., Scharenborg, Nicole M., van de Rakt, Mandy W.M.M., de Ruiter, Valeska, van Meeteren, Wilmy S., van Rossum, Michelle M., Croockewit, Sandra J., Koeneman, Bouke J., Creemers, Jeroen H.A., Wortel, Inge M.N., Angerer, Caroline, Brüning, Mareke, Petry, Katja, Dzionek, Andrzej, van der Veldt, Astrid A., van Grünhagen, Dirk J., Werner, Johanna E.M., Bonenkamp, Johannes J., Haanen, John B.A.G., Boers-Sonderen, Marye J., Koornstra, Rutger H.T., Boomsma, Martijn F., Aarntzen, Erik H.J., Gotthardt, Martin, Nagarajah, James, de Witte, Theo J.M., Figdor, Carl G., de Wilt, Johannes H.W., Textor, Johannes, de Groot, Jan Willem B., Gerritsen, Winald R., de Vries, I. Jolanda M., Bol, Kalijn F., Schreibelt, Gerty, Bloemendal, Martine, van Willigen, Wouter W., Hins-de Bree, Simone, de Goede, Anna L., de Boer, Annemiek J., Bos, Kevin J.H., Duiveman-de Boer, Tjitske, Olde Nordkamp, Michel A.M., van Oorschot, Tom G.M., Popelier, Carlijn J., Pots, Jeanne M., Scharenborg, Nicole M., van de Rakt, Mandy W.M.M., de Ruiter, Valeska, van Meeteren, Wilmy S., van Rossum, Michelle M., Croockewit, Sandra J., Koeneman, Bouke J., Creemers, Jeroen H.A., Wortel, Inge M.N., Angerer, Caroline, Brüning, Mareke, Petry, Katja, Dzionek, Andrzej, van der Veldt, Astrid A., van Grünhagen, Dirk J., Werner, Johanna E.M., Bonenkamp, Johannes J., Haanen, John B.A.G., Boers-Sonderen, Marye J., Koornstra, Rutger H.T., Boomsma, Martijn F., Aarntzen, Erik H.J., Gotthardt, Martin, Nagarajah, James, de Witte, Theo J.M., Figdor, Carl G., de Wilt, Johannes H.W., Textor, Johannes, de Groot, Jan Willem B., Gerritsen, Winald R., and de Vries, I. Jolanda M.

Abstract

Autologous natural dendritic cells (nDCs) treatment can induce tumor-specific immune responses and clinical responses in cancer patients. In this phase III clinical trial (NCT02993315), 148 patients with resected stage IIIB/C melanoma were randomized to adjuvant treatment with nDCs (n = 99) or placebo (n = 49). Active treatment consisted of intranodally injected autologous CD1c+ conventional and plasmacytoid DCs loaded with tumor antigens. The primary endpoint was the 2-year recurrence-free survival (RFS) rate, whereas the secondary endpoints included median RFS, 2-year and median overall survival, adverse event profile, and immunological response The 2-year RFS rate was 36.8% in the nDC treatment group and 46.9% in the control group (p = 0.31). Median RFS was 12.7 months vs 19.9 months, respectively (hazard ratio 1.25; 90% CI: 0.88−1.79; p = 0.29). Median overall survival was not reached in both treatment groups (hazard ratio 1.32; 90% CI: 0.73−2.38; p = 0.44). Grade 3−4 study-related adverse events occurred in 5% and 6% of patients. Functional antigen-specific T cell responses could be detected in 67.1% of patients tested in the nDC treatment group vs 3.8% of patients tested in the control group (p < 0.001). In conclusion, while adjuvant nDC treatment in stage IIIB/C melanoma patients generated specific immune responses and was well tolerated, no benefit in RFS was observed.

Published
2024

4. Blood-derived dendritic cell vaccinations induce immune responses that correlate with clinical outcome in patients with chemo-naive castration-resistant prostate cancer

Author

Westdorp, Harm, Creemers, Jeroen H. A., van Oort, Inge M., Schreibelt, Gerty, Gorris, Mark A. J., Mehra, Niven, Simons, Michiel, de Goede, Anna L., van Rossum, Michelle M., Croockewit, Alexandra J., Figdor, Carl G., Witjes, J. Alfred, Aarntzen, Erik H. J. G., Mus, Roel D. M., Brüning, Mareke, Petry, Katja, Gotthardt, Martin, Barentsz, Jelle O., de Vries, I. Jolanda M., and Gerritsen, Winald R.

Published
2019
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5. Supplementary Figure from Convection Enhanced Delivery of the Oncolytic Adenovirus Delta24-RGD in Patients with Recurrent GBM: A Phase I Clinical Trial Including Correlative Studies

Author

van Putten, Erik H.P., primary, Kleijn, Anne, primary, van Beusechem, Victor W., primary, Noske, David, primary, Lamers, Cor H.J., primary, de Goede, Anna L., primary, Idema, Sander, primary, Hoefnagel, Daphna, primary, Kloezeman, Jenneke J., primary, Fueyo, Juan, primary, Lang, Frederick F., primary, Teunissen, Charlotte E., primary, Vernhout, René M., primary, Bakker, Cathy, primary, Gerritsen, Winald, primary, Curiel, David T., primary, Vulto, Arnold, primary, Lamfers, Martine L.M., primary, and Dirven, Clemens M.F., primary

Published
2023
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6. Supplementary Data from Convection Enhanced Delivery of the Oncolytic Adenovirus Delta24-RGD in Patients with Recurrent GBM: A Phase I Clinical Trial Including Correlative Studies

Author

van Putten, Erik H.P., primary, Kleijn, Anne, primary, van Beusechem, Victor W., primary, Noske, David, primary, Lamers, Cor H.J., primary, de Goede, Anna L., primary, Idema, Sander, primary, Hoefnagel, Daphna, primary, Kloezeman, Jenneke J., primary, Fueyo, Juan, primary, Lang, Frederick F., primary, Teunissen, Charlotte E., primary, Vernhout, René M., primary, Bakker, Cathy, primary, Gerritsen, Winald, primary, Curiel, David T., primary, Vulto, Arnold, primary, Lamfers, Martine L.M., primary, and Dirven, Clemens M.F., primary

Published
2023
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7. DC immunotherapy in HIV-1 infection induces a major blood transcriptome shift

Author

Allard, Sabine D., van Baalen, Carel A., De Keersmaecker, Brenda, van der Ende, Marchina E., Thielemans, Kris, Lacor, Patrick, de Goede, Anna L., Andeweg, Arno C., van den Ham, Henk-Jan, Bijl, Maarten A., Zaaraoui-Boutahar, Fatiha, van IJcken, Wilfred F.J., Wilgenhof, Sofie, Aerts, Joeri L., Gruters, Rob A., and Osterhaus, Albert D.M.E.

Published
2015
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8. Convection Enhanced Delivery of the Oncolytic Adenovirus Delta24-RGD in Patients with Recurrent GBM:A Phase I Clinical Trial Including Correlative Studies

Author

Van Putten, Erik H.P., Kleijn, Anne, Van Beusechem, Victor W., Noske, David, Lamers, Cor H.J., De Goede, Anna L., Idema, Sander, Hoefnagel, Daphna, Kloezeman, Jenneke J., Fueyo, Juan, Lang, Frederick F., Teunissen, Charlotte E., Vernhout, Rene M., Bakker, Cathy, Gerritsen, Winald, Curiel, David T., Vulto, Arnold, Lamfers, Martine L.M., Dirven, Clemens M.F., Van Putten, Erik H.P., Kleijn, Anne, Van Beusechem, Victor W., Noske, David, Lamers, Cor H.J., De Goede, Anna L., Idema, Sander, Hoefnagel, Daphna, Kloezeman, Jenneke J., Fueyo, Juan, Lang, Frederick F., Teunissen, Charlotte E., Vernhout, Rene M., Bakker, Cathy, Gerritsen, Winald, Curiel, David T., Vulto, Arnold, Lamfers, Martine L.M., and Dirven, Clemens M.F.

Abstract

Purpose: Testing safety of Delta24-RGD (DNX-2401), an oncolytic adenovirus, locally delivered by convection enhanced delivery (CED) in tumor and surrounding brain of patients with recurrent glioblastoma. Patients and Methods: Dose-escalation phase I study with 3+3 cohorts, dosing 107to 1 × 1011viral particles (vp) in 20 patients. Besides clinical parameters, adverse events, and radiologic findings, blood, cerebrospinal fluid (CSF), brain interstitial fluid, and excreta were sampled over time and analyzed for presence of immune response, viral replication, distribution, and shedding. Results: Of 20 enrolled patients, 19 received the oncolytic adenovirus Delta24-RGD, which was found to be safe and feasible. Four patients demonstrated tumor response on MRI, one with complete regression and still alive after 8 years. Most serious adverse events were attributed to increased intracranial pressure caused by either an inflammatory reaction responding to steroid treatment or viral meningitis being transient and self-limiting. Often viral DNA concentrations in CSF increased over time, peaking after 2 to 4 weeks and remaining up to 3 months. Concomitantly Th1- and Th2- associated cytokine levels and numbers of CD3+T and natural killer cells increased. Posttreatment tumor specimens revealed increased numbers of macrophages and CD4+and CD8+T cells. No evidence of viral shedding in excreta was observed. Conclusions: CED of Delta24-RGD not only in the tumor but also in surrounding brain is safe, induces a local inflammatory reaction, and shows promising clinical responses.

Published
2022

10. Convection Enhanced Delivery of the Oncolytic Adenovirus Delta24-RGD in Patients with Recurrent GBM: A Phase I Clinical Trial Including Correlative Studies

Author

van Putten, Erik H.P., primary, Kleijn, Anne, additional, van Beusechem, Victor W., additional, Noske, David, additional, Lamers, Cor H.J., additional, de Goede, Anna L., additional, Idema, Sander, additional, Hoefnagel, Daphna, additional, Kloezeman, Jenneke J., additional, Fueyo, Juan, additional, Lang, Frederick F., additional, Teunissen, Charlotte E., additional, Vernhout, René M., additional, Bakker, Cathy, additional, Gerritsen, Winald, additional, Curiel, David T., additional, Vulto, Arnold, additional, Lamfers, Martine L.M., additional, and Dirven, Clemens M.F., additional

Published
2022
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11. Immunological responses to adjuvant vaccination with combined CD1c+ myeloid and plasmacytoid dendritic cells in stage III melanoma patients

Author

Bloemendal, Martine, primary, Bol, Kalijn F., additional, Boudewijns, Steve, additional, Gorris, Mark A.J., additional, de Wilt, Johannes H.W., additional, Croockewit, Sandra A.J., additional, van Rossum, Michelle M., additional, de Goede, Anna L., additional, Petry, Katja, additional, Koornstra, Rutger H.T., additional, Figdor, Carl, additional, Gerritsen, Winald R., additional, Schreibelt, Gerty, additional, and de Vries, I. Jolanda M., additional

Published
2021
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12. What does cell therapy manufacturing cost?: a framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

Author

Ten Ham, Renske M T, Hövels, Anke M, Hoekman, Jarno, Frederix, Geert W J, Leufkens, Hubert G M, Klungel, Olaf H, Jedema, Inge, Veld, Sabrina A J, Nikolic, Tatjana, Van Pel, Melissa, Zwaginga, Jaap J, Lin, Fong, de Goede, Anna L, Schreibelt, Gerty, Budde, Sandy, de Vries, I Jolanda M, Wilkie, Gwen M, Dolstra, Harry, Ovelgönne, Hans, Meij, Pauline, Mountford, Joanne C, Turner, Marc L, Hoefnagel, Marcel H N, Innovation Studies, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Innovation Studies, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
0301 basic medicine, Cancer Research, Cost estimate, Computer science, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Best practice, Supply chain, Immunology, Cell- and Tissue-Based Therapy, 03 medical and health sciences, 0302 clinical medicine, cell and gene therapies, Humans, Immunology and Allergy, Operations management, Activity-based costing, Genetics (clinical), cell-based therapies, Transplantation, cost framework, Academies and Institutes, Commerce, advanced therapy medicinal products, Cell Biology, cost methodology, Manufacturing cost, Europe, Product (business), manufacturing cost, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], 030104 developmental biology, Oncology, Cost driver, 030220 oncology & carcinogenesis, Scale (social sciences), Costs and Cost Analysis, Health Facilities
Abstract

Contains fulltext : 220591.pdf (Publisher’s version ) (Open Access) BACKGROUND AIMS: Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies. METHODS: We conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€). RESULTS: The framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to help design manufacturing best practices. CONCLUSIONS: This framework and methodology provide step-by-step guidance to estimate manufacturing costs specifically for cell-based therapies manufactured in academic and other small-scale enterprises. The framework and methodology can be used to inform and plan cost-conscious strategies for CBTs. 01 juli 2020

Published
2020

13. What does cell therapy manufacturing cost?: A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

Author

Innovation Studies, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Ten Ham, Renske M T, Hövels, Anke M, Hoekman, Jarno, Frederix, Geert W J, Leufkens, Hubert G M, Klungel, Olaf H, Jedema, Inge, Veld, Sabrina A J, Nikolic, Tatjana, Van Pel, Melissa, Zwaginga, Jaap J, Lin, Fong, de Goede, Anna L, Schreibelt, Gerty, Budde, Sandy, de Vries, I Jolanda M, Wilkie, Gwen M, Dolstra, Harry, Ovelgönne, Hans, Meij, Pauline, Mountford, Joanne C, Turner, Marc L, Hoefnagel, Marcel H N, Innovation Studies, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Ten Ham, Renske M T, Hövels, Anke M, Hoekman, Jarno, Frederix, Geert W J, Leufkens, Hubert G M, Klungel, Olaf H, Jedema, Inge, Veld, Sabrina A J, Nikolic, Tatjana, Van Pel, Melissa, Zwaginga, Jaap J, Lin, Fong, de Goede, Anna L, Schreibelt, Gerty, Budde, Sandy, de Vries, I Jolanda M, Wilkie, Gwen M, Dolstra, Harry, Ovelgönne, Hans, Meij, Pauline, Mountford, Joanne C, Turner, Marc L, and Hoefnagel, Marcel H N

Published
2020

15. Immunological responses to adjuvant vaccination with combined CD1c+ myeloid and plasmacytoid dendritic cells in stage III melanoma patients.

Author

Bloemendal, Martine, Bol, Kalijn F., Boudewijns, Steve, Gorris, Mark A. J., de Wilt, Johannes H. W., Croockewit, Sandra A. J., van Rossum, Michelle M., de Goede, Anna L., Petry, Katja, Koornstra, Rutger H. T., Figdor, Carl, Gerritsen, Winald R., Schreibelt, Gerty, and de Vries, I. Jolanda M.

Subjects
DENDRITIC cells, IMMUNOLOGICAL adjuvants, MYELOID cells, VACCINATION, MELANOMA
Abstract

We evaluated the immunological responses of lymph-node involved (stage III) melanoma patients to adjuvant dendritic cell vaccination with subsets of naturally occurring dendritic cells (nDCs). Fifteen patients with completely resected stage III melanoma were randomized to receive adjuvant dendritic cell vaccination with CD1c+ myeloid dendritic cells (cDC2s), plasmacytoid dendritic cells (pDCs) or the combination. Immunological response was the primary endpoint and secondary endpoints included safety and survival. In 80% of the patients, antigen-specific CD8+ T cells were detected in skin test-derived T cells and in 55% of patients, antigen-specific CD8+ T cells were detectable in peripheral blood. Functional interferon-γ-producing T cells were found in the skin test of 64% of the patients. Production of nDC vaccines meeting release criteria was feasible for all patients. Vaccination only induced grade 1-2 adverse events, mainly consisting of fatigue. In conclusion, adjuvant dendritic cell vaccination with cDC2s and/or pDCs is feasible, safe and induced immunological responses in the majority of stage III melanoma patients. [ABSTRACT FROM AUTHOR]

Published
2022
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16. Myeloid and plasmacytoid dendritic cell vaccinations for castration-resistant prostate cancer patients.

Author

Westdorp, Harm, primary, van Oort, Inge M., additional, Creemers, Jeroen H.A., additional, Schreibelt, Gerty, additional, Mehra, Niven, additional, de Goede, Anna L., additional, Hulsbergen-Van De Kaa, Christina, additional, Figdor, Carl G., additional, Witjes, Alfred, additional, Aarntzen, Erik H.J.G., additional, Mus, Roel D.M., additional, Gotthardt, Martin, additional, Barentsz, Jelle O., additional, De Vries, Jolanda, additional, and Gerritsen, Winald R., additional

Published
2018
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17. Adjuvant Dendritic Cell Vaccination in High-Risk Uveal Melanoma

Author

Bol, Kalijn F., primary, van den Bosch, Thomas, additional, Schreibelt, Gerty, additional, Mensink, Hanneke W., additional, Keunen, Jan E.E., additional, Kiliç, Emine, additional, Japing, Wouter J., additional, Geul, Kaspar W., additional, Westdorp, Harm, additional, Boudewijns, Steve, additional, Croockewit, Sandra A.J., additional, van Rossum, Michelle M., additional, de Goede, Anna L., additional, Naus, Nicole C., additional, van der Graaf, Winette T.A., additional, Gerritsen, Winald R., additional, de Klein, Annelies, additional, Punt, Cornelis J.A., additional, Figdor, Carl G., additional, Cohen, Victoria M., additional, Paridaens, Dion, additional, and de Vries, I. Jolanda M., additional

Published
2016
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18. DC immunotherapy in HIV-1 infection induces a major blood transcriptome shift

Author

de Goede, Anna L., primary, Andeweg, Arno C., additional, van den Ham, Henk-Jan, additional, Bijl, Maarten A., additional, Zaaraoui-Boutahar, Fatiha, additional, van IJcken, Wilfred F.J., additional, Wilgenhof, Sofie, additional, Aerts, Joeri L., additional, Gruters, Rob A., additional, Osterhaus, Albert D.M.E., additional, Allard, Sabine D., additional, van Baalen, Carel A., additional, De Keersmaecker, Brenda, additional, van der Ende, Marchina E., additional, Thielemans, Kris, additional, and Lacor, Patrick, additional

Published
2015
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19. Corrigendum to ‘A phase I/IIa immunotherapy trial of HIV-1-infected patients with Tat, Rev and Nef expressing dendritic cells followed by treatment interruption’ [Clin. Immunol. 142 (2012) 252–268]

Author

Allard, Sabine D., primary, De Keersmaecker, Brenda, additional, de Goede, Anna L., additional, Verschuren, Esther J., additional, Koetsveld, Jeanette, additional, Reedijk, Mariska L., additional, Wylock, Carolien, additional, De Bel, Annelies V., additional, Vandeloo, Judith, additional, Pistoor, Frank, additional, Heirman, Carlo, additional, Beyer, Walter E.P., additional, Eilers, Paul H.C., additional, Corthals, Jurgen, additional, Padmos, Iman, additional, Thielemans, Kris, additional, Osterhaus, Albert D.M.E., additional, Lacor, Patrick, additional, van der Ende, Marchina E., additional, Aerts, Joeri L., additional, van Baalen, Carel A., additional, and Gruters, Rob A., additional

Published
2014
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20. A phase I/IIa immunotherapy trial of HIV-1-infected patients with Tat, Rev and Nef expressing dendritic cells followed by treatment interruption

Author

Allard, Sabine D., primary, De Keersmaecker, Brenda, additional, de Goede, Anna L., additional, Verschuren, Esther J., additional, Koetsveld, Jeanette, additional, Reedijk, Mariska L., additional, Wylock, Carolien, additional, De Bel, Annelies V., additional, Vandeloo, Judith, additional, Pistoor, Frank, additional, Heirman, Carlo, additional, Beyer, Walter E.P., additional, Eilers, Paul H.C., additional, Corthals, Jurgen, additional, Padmos, Iman, additional, Thielemans, Kris, additional, Osterhaus, Albert D.M.E., additional, Lacor, Patrick, additional, der Ende, Marchina E. van, additional, Aerts, Joeri L., additional, van Baalen, Carel A., additional, and Gruters, Rob A., additional

Published
2012
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22. Immunological responses to adjuvant vaccination with combined CD1c+myeloid and plasmacytoid dendritic cells in stage III melanoma patients

Author

Bloemendal, Martine, Bol, Kalijn F., Boudewijns, Steve, Gorris, Mark A.J., de Wilt, Johannes H.W., Croockewit, Sandra A.J., van Rossum, Michelle M., de Goede, Anna L., Petry, Katja, Koornstra, Rutger H.T., Figdor, Carl, Gerritsen, Winald R., Schreibelt, Gerty, and de Vries, I. Jolanda M.

Abstract

ABSTRACTWe evaluated the immunological responses of lymph-node involved (stage III) melanoma patients to adjuvant dendritic cell vaccination with subsets of naturally occurring dendritic cells (nDCs). Fifteen patients with completely resected stage III melanoma were randomized to receive adjuvant dendritic cell vaccination with CD1c+myeloid dendritic cells (cDC2s), plasmacytoid dendritic cells (pDCs) or the combination. Immunological response was the primary endpoint and secondary endpoints included safety and survival. In 80% of the patients, antigen-specific CD8+T cells were detected in skin test-derived T cells and in 55% of patients, antigen-specific CD8+T cells were detectable in peripheral blood. Functional interferon-γ-producing T cells were found in the skin test of 64% of the patients. Production of nDC vaccines meeting release criteria was feasible for all patients. Vaccination only induced grade 1–2 adverse events, mainly consisting of fatigue. In conclusion, adjuvant dendritic cell vaccination with cDC2s and/or pDCs is feasible, safe and induced immunological responses in the majority of stage III melanoma patients.

Published
2022
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23. Fully closed and automated enrichment of primary blood dendritic cells for cancer immunotherapy.

Author

Schreibelt G, Duiveman-de Boer T, Pots JM, van Oorschot TGM, de Boer AJ, Scharenborg NM, van de Rakt MWMM, Bos K, de Goede AL, Petry K, Brüning M, Angerer C, Schöggl C, Dzionek A, and de Vries IJM

Subjects
Male, Humans, Immunotherapy methods, Dendritic Cells physiology, Melanoma, Prostatic Neoplasms, Vaccines
Abstract

Dendritic cell (DC) vaccination is a promising approach to induce tumor-specific immune responses in cancer patients. Until recently, most DC vaccines were based on in vitro-differentiated monocyte-derived DCs. However, through development of efficient isolation techniques, the use of primary blood dendritic cell subsets has come within reach. Manufacturing of blood-derived DCs has multiple advances over monocytes-derived DCs, including more standardized isolation and culture protocols and shorter production processes. In peripheral blood, multiple DC subsets can be distinguished based on their phenotype and function. Plasmacytoid DC (pDC) and myeloid/conventional DCs (cDC) are the two main DC populations, moreover cDC can be further subdivided into CD141/BDCA3 + DC (cDC1) and CD1c/BDCA1 + DC (cDC2). In three separate clinical DC vaccination studies in melanoma and prostate cancer patients, we manufactured DC vaccines consisting of pDCs only, cDC2s only, or a combination of pDC and cDC2s, which we called natural DCs (nDC). Here, we describe a fully closed and automated GMP-compliant method to enrich naturally circulating DCs and present the results of enrichment of primary blood DCs from aphaeresis products of 8 healthy donors, 21 castrate-resistant prostate cancer patients, and 112 stage III melanoma patients. Although primary blood DCs are relatively scarce in aphaeresis material, our results show that it is feasible to isolate highly pure pDC, cDC2, or nDC with sufficient yield to manufacture DC vaccines for natural DC-based immunotherapy., Competing Interests: Conflict of interest K.P., M.B., A.D., C.A. and C.S. are employees of Miltenyi Biomedicine or Biotec. All other authors declare not conflict of interest., (Copyright © 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
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24. Immunological responses to adjuvant vaccination with combined CD1c + myeloid and plasmacytoid dendritic cells in stage III melanoma patients.

Author

Bloemendal M, Bol KF, Boudewijns S, Gorris MAJ, de Wilt JHW, Croockewit SAJ, van Rossum MM, de Goede AL, Petry K, Koornstra RHT, Figdor C, Gerritsen WR, Schreibelt G, and de Vries IJM

Subjects
Humans, CD8-Positive T-Lymphocytes, Dendritic Cells, Adjuvants, Immunologic, Vaccination, Glycoproteins, Antigens, CD1, Melanoma, Cutaneous Malignant, Cancer Vaccines therapeutic use, Melanoma therapy
Abstract

We evaluated the immunological responses of lymph-node involved (stage III) melanoma patients to adjuvant dendritic cell vaccination with subsets of naturally occurring dendritic cells (nDCs). Fifteen patients with completely resected stage III melanoma were randomized to receive adjuvant dendritic cell vaccination with CD1c + myeloid dendritic cells (cDC2s), plasmacytoid dendritic cells (pDCs) or the combination. Immunological response was the primary endpoint and secondary endpoints included safety and survival. In 80% of the patients, antigen-specific CD8 + T cells were detected in skin test-derived T cells and in 55% of patients, antigen-specific CD8 + T cells were detectable in peripheral blood. Functional interferon-γ-producing T cells were found in the skin test of 64% of the patients. Production of nDC vaccines meeting release criteria was feasible for all patients. Vaccination only induced grade 1-2 adverse events, mainly consisting of fatigue. In conclusion, adjuvant dendritic cell vaccination with cDC2s and/or pDCs is feasible, safe and induced immunological responses in the majority of stage III melanoma patients., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.)

Published
2021
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25. What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings.

Author

Ten Ham RMT, Hövels AM, Hoekman J, Frederix GWJ, Leufkens HGM, Klungel OH, Jedema I, Veld SAJ, Nikolic T, Van Pel M, Zwaginga JJ, Lin F, de Goede AL, Schreibelt G, Budde S, de Vries IJM, Wilkie GM, Dolstra H, Ovelgönne H, Meij P, Mountford JC, Turner ML, and Hoefnagel MHN

Subjects
Commerce, Europe, Health Facilities, Humans, Academies and Institutes, Cell- and Tissue-Based Therapy economics, Costs and Cost Analysis
Abstract

Background Aims: Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies., Methods: We conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€)., Results: The framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to help design manufacturing best practices., Conclusions: This framework and methodology provide step-by-step guidance to estimate manufacturing costs specifically for cell-based therapies manufactured in academic and other small-scale enterprises. The framework and methodology can be used to inform and plan cost-conscious strategies for CBTs., (Copyright © 2020 International Society for Cell and Gene Therapy. All rights reserved.)

Published
2020
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