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
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<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 --> 2040-01</p><p><b>sponsor</b>: <a href="Organization-mii-exa-mtb-study-sponsor-biontech.html">Organization BioNTech Cell & 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>
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