Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer

This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care. The study consists of two phases: Phase I employs an accelerated titration combined with a "3+3" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Phase II further assesses the objective response rate (O

Trial Details

NCT ID
NCT07559097
Phase
PHASE1 / PHASE2
Sponsor
Henan Cancer Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Methotrexate-loaded vesicles
Locations (sample)
  • Zhengzhou, Henan, China|34.75778,113.64861

Key Eligibility Criteria

  • Participants can be enrolled in this study only if they meet all of the following inclusion criteria:
  • Age ≥ 18 years old;
  • Diagnosed with lung cancer by pathological biopsy or cytology;
  • Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;

For full eligibility, visit ClinicalTrials.gov.

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