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Cancer Immunology Research
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Clinical Trials of Cancer Immunotherapies

Abstract B002: TLR7/8-matured dendritic cells for therapeutic vaccination in AML: Results of a clinical Phase I/II trial

Katrin Deiser, Felix S. Lichtenegger, Frauke M. Schnorfeil, Thomas Köhnke, Torben Altmann, Veit Bücklein, Christian Augsberger, Andreas Moosmann, Monika Brüggemann, Mirjam HM Heemskerk, Beate Wagner, Wolfgang Hiddemann, Iris Bigalke, Gunnar Kvalheim and Marion Subklewe
Katrin Deiser
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Felix S. Lichtenegger
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Frauke M. Schnorfeil
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Thomas Köhnke
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Torben Altmann
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Veit Bücklein
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Christian Augsberger
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Andreas Moosmann
2Clinical Cooperation Group Immunotherapy at the Helmholtz Zentrum München, Munich, Germany;
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Monika Brüggemann
3Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany;
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Mirjam HM Heemskerk
4Department of Hematology, Leiden University Medical Center, Leiden, Netherlands;
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Beate Wagner
5Department of Transfusion Medicine, Cellular Therapeutics and Hemostaseology, Klinikum der Universität München, LMU Munich, Munich, Germany;
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Wolfgang Hiddemann
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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Iris Bigalke
6Department of Cellular Therapy, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
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Gunnar Kvalheim
6Department of Cellular Therapy, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
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Marion Subklewe
1Klinikum der Universität München, LMU Munich, Munich, Germany;
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DOI: 10.1158/2326-6066.IMM2016-B002 Published November 2016
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Abstracts: Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival; September 25-28, 2016; New York, NY

Abstract

Postremission therapy for acute myeloid leukemia (AML) is critical for elimination of minimal residual disease (MRD). In patients not eligible for allogeneic stem cell transplantation, alternative treatment options are needed. Therapeutic vaccination with autologous dendritic cells (DCs) loaded with leukemia-associated antigens (LAAs) is a promising treatment strategy to induce anti-leukemic immune responses and to eradicate chemorefractory cells. Using a TLR7/8 agonist, we have developed a GMP-compliant 3-day protocol to differentiate monocytes of intensively pretreated AML patients into highly functional, therapeutic DCs.

A phase I/II proof-of-concept study has been initiated using TLR7/8-matured DCs as postremission therapy of AML patients with a non-favorable risk profile in CR or CRi after intensive induction therapy (NCT01734304). DCs have been loaded with in vitro transcribed RNA encoding the LAAs WT1 and PRAME as well as CMVpp65 as adjuvant and surrogate antigen. Patients have been vaccinated intradermally with 5×106 DCs of each antigen species up to 10 times within 26 weeks. The primary endpoint of the phase I/II trial is feasibility and safety of the vaccination. Secondary endpoints are immunological responses and disease control.

In total, 13 patients have been enrolled into the study. The first 6 patients were analysed in phase I for safety and toxicity of the DC vaccine. No higher grade toxicities were observed during their treatment and hence phase II has been initiated. DCs of sufficient number and quality were generated from leukapheresis in 10/11 cases. DCs exhibited an immune-stimulatory profile based on high surface expression of positive costimulatory molecules, the capacity to secrete IL-12p70, the migration towards a chemokine gradient and processing and presentation of antigen. In 9/9 vaccinated patients, we observed delayed-type hypersensitivity (DTH) responses at the vaccination site, accompanied by slight erythema and indurations at the injection site, but no grade III/IV toxicities. TCR repertoire analysis by NGS revealed an enrichment of particular clonotypes at DTH sites. In addition, we detected vaccine-specific T-cell responses by multimer staining and by Interferon-gamma-ELISPOT analysis: 7/7 patients showed responses to CMVpp65 and 2/7 exhibited responses to PRAME and WT1, respectively. In an individual treatment attempt, an enrolled patient with impending relapse was treated with a combination of DC vaccination and 5-azacytidine, resulting in MRD conversion. Long-term disease control and immunological responses are studied in the ongoing phase II trial.

We conclude that vaccination with TLR7/8-matured, LAA-expressing DCs in AML is feasible, safe and induces anti-leukemia-specific immune responses in vivo.

Citation Format: Katrin Deiser, Felix S. Lichtenegger, Frauke M. Schnorfeil, Thomas Köhnke, Torben Altmann, Veit Bücklein, Christian Augsberger, Andreas Moosmann, Monika Brüggemann, Mirjam HM Heemskerk, Beate Wagner, Wolfgang Hiddemann, Iris Bigalke, Gunnar Kvalheim, Marion Subklewe. TLR7/8-matured dendritic cells for therapeutic vaccination in AML: Results of a clinical Phase I/II trial [abstract]. In: Proceedings of the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival; 2016 Sept 25-28; New York, NY. Philadelphia (PA): AACR; Cancer Immunol Res 2016;4(11 Suppl):Abstract nr B002.

  • ©2016 American Association for Cancer Research.
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Cancer Immunology Research: 4 (11 Supplement)
November 2016
Volume 4, Issue 11 Supplement
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Abstract B002: TLR7/8-matured dendritic cells for therapeutic vaccination in AML: Results of a clinical Phase I/II trial
Katrin Deiser, Felix S. Lichtenegger, Frauke M. Schnorfeil, Thomas Köhnke, Torben Altmann, Veit Bücklein, Christian Augsberger, Andreas Moosmann, Monika Brüggemann, Mirjam HM Heemskerk, Beate Wagner, Wolfgang Hiddemann, Iris Bigalke, Gunnar Kvalheim and Marion Subklewe
Cancer Immunol Res November 1 2016 (4) (11 Supplement) B002; DOI: 10.1158/2326-6066.IMM2016-B002

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Abstract B002: TLR7/8-matured dendritic cells for therapeutic vaccination in AML: Results of a clinical Phase I/II trial
Katrin Deiser, Felix S. Lichtenegger, Frauke M. Schnorfeil, Thomas Köhnke, Torben Altmann, Veit Bücklein, Christian Augsberger, Andreas Moosmann, Monika Brüggemann, Mirjam HM Heemskerk, Beate Wagner, Wolfgang Hiddemann, Iris Bigalke, Gunnar Kvalheim and Marion Subklewe
Cancer Immunol Res November 1 2016 (4) (11 Supplement) B002; DOI: 10.1158/2326-6066.IMM2016-B002
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