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
identifier: MII_NS_MTB_NCT/04503278
status: Active
primaryPurposeType: treatment
phase: phase-1
condition: Solid tumor configuration
keyword: Non-small cell lung cancer (NSCLC)
enrollment: Group: type = person; actual = false; quantity = 145
period: 2020-09-16 --> 2040-01
sponsor: Organization BioNTech Cell & Gene Therapies GmbH
principalInvestigator: PractitionerRole Study coordinator
arm
name: Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D
arm
name: Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D
objective
name: Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
type: primary
objective
name: Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
type: primary
objective
name: Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
type: primary
objective
name: Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay
type: secondary
objective
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: secondary
objective
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: secondary
objective
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
type: secondary