FHIR IG analytics

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Source1

{
  "resourceType": "ResearchStudy",
  "id": "mii-exa-mtb-study-cldn6",
  "meta": {
    "profile": [
      "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie|2026.0.0"
    ]
  },
  "identifier": [
    {
      "system": "https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct",
      "value": "04503278"
    }
  ],
  "condition": [
    {
      "coding": [
        {
          "code": "369757002",
          "system": "http://snomed.info/sct",
          "display": "Solid tumor configuration"
        }
      ]
    }
  ],
  "keyword": [
    {
      "text": "Non-small cell lung cancer (NSCLC)"
    }
  ],
  "enrollment": [
    {
      "reference": "Group/mii-exa-mtb-study-cldn6-eligibility-criteria"
    }
  ],
  "period": {
    "start": "2020-09-16",
    "end": "2040-01"
  },
  "site": [
    {
      "reference": "Location/mii-exa-mtb-study-cldn6-location-11"
    }
  ],
  "arm": [
    {
      "name": "Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D"
    },
    {
      "name": "Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D"
    }
  ],
  "objective": [
    {
      "type": {
        "coding": [
          {
            "code": "primary"
          }
        ]
      },
      "name": "Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship"
    },
    {
      "type": {
        "coding": [
          {
            "code": "primary"
          }
        ]
      },
      "name": "Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs"
    },
    {
      "type": {
        "coding": [
          {
            "code": "primary"
          }
        ]
      },
      "name": "Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period"
    },
    {
      "type": {
        "coding": [
          {
            "code": "secondary"
          }
        ]
      },
      "name": "Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay"
    },
    {
      "type": {
        "coding": [
          {
            "code": "secondary"
          }
        ]
      },
      "name": "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"
    },
    {
      "type": {
        "coding": [
          {
            "code": "secondary"
          }
        ]
      },
      "name": "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"
    },
    {
      "type": {
        "coding": [
          {
            "code": "secondary"
          }
        ]
      },
      "name": "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"
    }
  ],
  "status": "active",
  "primaryPurposeType": {
    "coding": [
      {
        "code": "treatment"
      }
    ]
  },
  "phase": {
    "coding": [
      {
        "code": "phase-1"
      }
    ]
  },
  "sponsor": {
    "reference": "Organization/mii-exa-mtb-study-sponsor-biontech"
  },
  "principalInvestigator": {
    "reference": "PractitionerRole/mii-exa-mtb-study-investigator-biontech"
  }
}