Hence, 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

Method Portfolio

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

Trial Portfolio

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 ). Contribution of IMU: PBMC, serum and plasma processing , IFNᵞ-ELISpot assay, FACS, Luminex and TCR sequencing as part of translational research.

Cooperations and funding

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.

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