MII IG Kerndatensatz-Modul Molekulares Tumorboard
2026.0.0 - release Unknown region code '276'

MII IG Kerndatensatz-Modul Molekulares Tumorboard, published by Medizininformatik-Initiative. This guide is not an authorized publication; it is the continuous build for version 2026.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/medizininformatik-initiative/kerndatensatzmodul-molekulares-tumorboard/ and changes regularly. See the Directory of published versions

: A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "mii-exa-mtb-study-cldn6"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie|2026.0.0"^^xsd:anyURI ;
fhir:l <https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie?version=2026.0.0>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy mii-exa-mtb-study-cldn6</b></p><a name=\"mii-exa-mtb-study-cldn6\"> </a><a name=\"hcmii-exa-mtb-study-cldn6\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-mii-pr-mtb-studie.html\">MII PR MTB Studieversion: null2026.0.0)</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-mii-ns-mtb-nct.html\" title=\"NamingSystem für Identifikatoren des Nationalen Centrums für Tumorerkrankungen (NCT)\">MII_NS_MTB_NCT</a>/04503278</p><p><b>status</b>: Active</p><p><b>primaryPurposeType</b>: <span title=\"Codes:\">treatment</span></p><p><b>phase</b>: <span title=\"Codes:\">phase-1</span></p><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 369757002}\">Solid tumor configuration</span></p><p><b>keyword</b>: <span title=\"Codes:\">Non-small cell lung cancer (NSCLC)</span></p><p><b>enrollment</b>: <a href=\"Group-mii-exa-mtb-study-cldn6-eligibility-criteria.html\">Group: type = person; actual = false; quantity = 145</a></p><p><b>period</b>: 2020-09-16 --&gt; 2040-01</p><p><b>sponsor</b>: <a href=\"Organization-mii-exa-mtb-study-sponsor-biontech.html\">Organization BioNTech Cell &amp; Gene Therapies GmbH</a></p><p><b>principalInvestigator</b>: <a href=\"PractitionerRole-mii-exa-mtb-study-investigator-biontech.html\">PractitionerRole Study coordinator</a></p><p><b>site</b>: <a href=\"Location-mii-exa-mtb-study-cldn6-location-11.html\">Location Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset</a></p><blockquote><p><b>arm</b></p><p><b>name</b>: Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship</p><p><b>type</b>: <span title=\"Codes:\">primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs</p><p><b>type</b>: <span title=\"Codes:\">primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period</p><p><b>type</b>: <span title=\"Codes:\">primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay</p><p><b>type</b>: <span title=\"Codes:\">secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response</p><p><b>type</b>: <span title=\"Codes:\">secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response</p><p><b>type</b>: <span title=\"Codes:\">secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first</p><p><b>type</b>: <span title=\"Codes:\">secondary</span></p></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct"^^xsd:anyURI ;
fhir:l <https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct>     ] ;
fhir:value [ fhir:v "04503278" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:primaryPurposeType [
    ( fhir:coding [
fhir:code [ fhir:v "treatment" ]     ] )
  ] ; # 
  fhir:phase [
    ( fhir:coding [
fhir:code [ fhir:v "phase-1" ]     ] )
  ] ; # 
  fhir:condition ( [
    ( fhir:coding [
a sct:369757002 ;
fhir:system [
fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
fhir:l <http://snomed.info/sct>       ] ;
fhir:code [ fhir:v "369757002" ] ;
fhir:display [ fhir:v "Solid tumor configuration" ]     ] )
  ] ) ; # 
  fhir:keyword ( [
fhir:text [ fhir:v "Non-small cell lung cancer (NSCLC)" ]
  ] ) ; # 
  fhir:enrollment ( [
fhir:l fhir:Group/mii-exa-mtb-study-cldn6-eligibility-criteria ;
fhir:reference [ fhir:v "Group/mii-exa-mtb-study-cldn6-eligibility-criteria" ]
  ] ) ; # 
  fhir:period [
fhir:start [ fhir:v "2020-09-16"^^xsd:date ] ;
fhir:end [ fhir:v "2040-01"^^xsd:gYearMonth ]
  ] ; # 
  fhir:sponsor [
fhir:l fhir:Organization/mii-exa-mtb-study-sponsor-biontech ;
fhir:reference [ fhir:v "Organization/mii-exa-mtb-study-sponsor-biontech" ]
  ] ; # 
  fhir:principalInvestigator [
fhir:l fhir:PractitionerRole/mii-exa-mtb-study-investigator-biontech ;
fhir:reference [ fhir:v "PractitionerRole/mii-exa-mtb-study-investigator-biontech" ]
  ] ; # 
  fhir:site ( [
fhir:l fhir:Location/mii-exa-mtb-study-cldn6-location-11 ;
fhir:reference [ fhir:v "Location/mii-exa-mtb-study-cldn6-location-11" ]
  ] ) ; # 
  fhir:arm ( [
fhir:name [ fhir:v "Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D" ]
  ] [
fhir:name [ fhir:v "Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D" ]
  ] ) ; # 
  fhir:objective ( [
fhir:name [ fhir:v "Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "primary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "primary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "primary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "secondary" ]       ] )     ]
  ] [
fhir:name [ fhir:v "Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first" ] ;
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "secondary" ]       ] )     ]
  ] ) . #