Contact

     Prof. Dr. M. Platten
     +49 6221 56-7107
     E-mail»

 

     Dennis Riehl
     +49 6221 56-35210
     E-mail»

Immunomonitoring...

 

in clinical trials.

Immune Monitoring Unit (IMU)

DKFZ
 
 
 

The IMU’s mission is to offer immune monitoring for NCT-based IITs but also industry-sponsored trials (phase 0-4). In addition to guidance for immune monitoring designs for study protocols and grant proposals we offer state-of-the-art validated and individually adapted immune assays including:

  • High-quality, standardized acquisition and storage of patient biosamples including fresh frozen PBMC, serum and nucleic acids
  • Monitoring of intervention specific central immune parameters as primary, secondary or tertiary endpoints of immunotherapeutic clinical trials.
  • Correlation of the presence and magnitude of intervention induced immune responses to clinical outcomes.
  • Identification of biological and functional relevant immune parameter as response to immunological interventions
  • Translation of these novel findings to models or adequate novel clinical trials
  • QC of cellular therapies
  • Definition of appropriate patient populations for trials
  • Translating findings into new hypotheses for therapeutic targets

Valid methods:

  • Isolation of PBMCs, serum, plasma from bioliquids
  • Monitoring of specific T cell responses via ELISpot Assay
  • Antibody profiling via ELISA
  • Cytokine profiling via LUMINEX
  • Monitoring of leukocyte phenotype changes by FACS
  • Monitoring of specific Treg induction via Treg specificity assay

In development:

  • Isolation of TILs  from tumor tissue
  • Monitoring of expansion of specific T cells clones by TCR Sequencing
  • IFNᵞ-Catch Assay
  • HLA-Typing

NOA-16 Targeting IDH1R132H in WHO grade III-IV IDH1R132Hmutated gliomas by a peptide vaccine – a Phase I safety, tolerability and immunogenicity multicenter trial (EudraCT 2014-000503-27). Contribution of IMU: PBMC, serum and plasma processing for and IFNᵞ-ELISpot assay and IDH1R132H antibody response via ELISA as part of the primary endpoint analysis.

POSITIVE III Physical exercise program in lung cancer patients with non-operable disease undergoing palliative treatment - Lung Cancer Study - (NCT02055508). Contribution of IMU: PBMC, serum and plasma processing for and IFNᵞ-ELISpot assays, Cytokine screening and Treg FACS as part of the secondary endpoint analysis.

TNBC-MERIT / BN_0002-01 RNA Vaccination of breast tumor patients. Contribution of IMU: PBMC processing as part of the secondary endpoint analysis.

VXM01-02-DE VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01 (EudraCT 2015-003067-10). Contribution of IMU: PBMC processing and IFNᵞ-ELISpot assay as part of the secondary endpoint analysis.

VXM01-03-DE VXM01 phase I study in patients with metastatic colorectal cancer with liver metastasis under second or third line therapy to examine safety, efficacy, and immune biomarkers after treatment with VXM01 (EudraCT 2015-003068-34). Contribution of IMU: PBMC processing as part of the secondary endpoint analysis.

ATACC Phase I Trial of Adoptive T cell Therapy with Activated P53 Specific T cells for Treatment of Advanced Colorectal Cancer  (EudraCT 2013-000064-28). Contribution of IMU: QC of product process (p53+ T cell isolation), screening and monitoring of p53+ T cell responses via IFNᵞ-ELISpot assay.

FORCE Fostering efficacy of anti – PD-1 – treatment: Nivolumab plus radiotherapy in advanced NSCLC , Open label phase II trial (EudraCT 2015-005741-31 ). Beitrag der IMU: PBMC, Serum und Plasma Isolation, IFNᵞ-ELISpot Assay, FACS auf Checkpoint Inhibitoren, Luminex und TCR Sequenzierung als Teil des translationalen Forschungsprojektes.

  • Gebhardt C, Sevko A, Jiang H, Lichtenberger R, Reith M, Tarnanidis K, Holland-Letz, T., Umansky L, Beckhove P, Sucker A, Schadendorf D, Utikal J, Umansky V. Myeloid Cells and Related Chronic Inflammatory Factors as Novel Predictive Markers in Melanoma Treatment with Ipilimumab. Clin. Cancer Res., 2015, DOI:10.158/1078-0432.CCR-15-0676.

  • Schneider T, Sevko A, Heussel CP, Umansky L, Beckhove P, Dienemann H, Safi S, Utikal J, Hoffmann H, Umansky V. Serum inflammatory factors and circulating immunosuppressive cells are predictive markers for efficacy of radiofrequency ablation in non-small cell lung cancer. Clin Exp Immunol. 2015, 180:467-474.

  • Schmitz-Winnenthal FH, Hohmann N, Niethammer AG, Friedrich T, Lubenau H, Springer M, Breiner KM, Mikus G, Weitz J, Ulrich A, Buechler MW, Pianka F, Klaiber U, Diener M, Leowardi C, Schimmack S, Sisic L, Keller AV, Koc R, Springfeld C, Knebel P, Schmidt T, Ge Y, Bucur M, Stamova S, Podola L, Haefeli WE, Grenacher L, Beckhove P. Anti-angiogenic activity of VXM01, an oral T-cell vaccine against VEGF receptor 2, in patients with advanced pancreatic cancer: A randomized, placebo-controlled, phase 1 trial. Oncoimmunology. 2015 Mar 16;4(4):1001217. eCollection 2015 Apr.

  • Domschke C., Ge Y., Bernahrd I., Schott S., Keim S., Juenger S., Bucur M., Mayer L., Blumenstein M., Rom J., Heil J., Sohn C., Schneeweiss A., Beckhove P., Schetz F., Long-term survival after adoptive bone marrow T cell therapy of advanced metastasized brest cancer: follow-up analysis of clinical pilot trial. Cancer Immunol Immunother. 2013 Jun;62(6):1053-60. Doi: 10.1007/s00262-013-1414-x Epub 2013 Apr 18.

  • Wiskemann J., Hummler S., Diepold C., Keil M., Abel U., Steindorf K., Beckhove P., Ulrich C.M., Steins M. and Thomas M.; POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment. BMC Cancer. 2016 Jul 16:499 DOI: 10.1186/s12885-016-2561-1

The IMU is embedded in the Heidelberg Cancer Immunotherapy Program at the NCT, DKFZ and HUMS, which focuses on patient-tailored vaccines and T cell therapies. It is supported by the NCT 3.0 program and it cooperates with the GMP Unit, the Bayer-DKFZ Joint Immunotherapy Lab and the Tumor Immunology Program at the DKFZ.

Prof. Dr. med. Michael Platten
Arbeitsgruppenleiter
m.platten@dkfz.de
Phone: +49 6221 56-7107
Fax: +49 6221 56-7554

Mariana Bucur
MTA
m.bucur@dkfz.de
Phone: +49 6221 56-35185
Fax: +49 6221 56-5280

Dipl. Biologin Elvira Hallauer
BTA
e.hallauer@dkfz.de
Phone: +49 6221 56-5980
Fax: +49 6221 56-5280

Simone Jünger
BTA
s.juenger@dkfz.de
Phone: +49 6221 56-35209
Fax: +49 6221 56-5280

Dennis Riehl
Laborleiter
d.riehl@dkfz.de
Phone: +49 6221 56-35210
Fax: +49 6221 56-5280

Ludmila Umansky
BTA
l.umansky@dkfz.de
Phone: +49 6221 56-5980
Fax: +49 6221 56-5280

Sandra Bauer
Biologielaborantin
s.bauer@dkfz.de
Phone: +49 6221 56-5989
Fax: +49 6221 56-5280