NCT07559097 Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
| NCT ID | NCT07559097 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | Leptomeningeal Metastasis From Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2025-09-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 (ORR) at the RP2D. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile. Approximately 10-20 patients with cytologically confirmed leptomeningeal metastasis (age ≥18 years, ECOG PS 0-3) will be enrolled. Participants will receive intrathecal MTX-MPs on days 1, 3, and 5 of the first cycle, followed by once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or death. Tumor response will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for leptomeningeal metastasis, and adverse events will be graded according to CTCAE version 5.0. This exploratory study may provide a novel local therapeutic approach for leptomeningeal metastasis from lung cancer.
Eligibility Criteria
Inclusion Criteria: \- Participants can be enrolled in this study only if they meet all of the following inclusion criteria: 1. Age ≥ 18 years old; 2. Diagnosed with lung cancer by pathological biopsy or cytology; 3. Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology; 4. Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment; 5. ECOG PS 0 - 3. Exclusion Criteria: \- The following conditions will disqualify a patient from participating in this study: 1. Concurrent central nervous system infectious diseases; 2. ECOG PS ≥ 4; 3. Patients currently participating in other interventional studies; 4. History of or current severe immunodeficiency diseases; 5. Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.
Frequently Asked Questions
Who can join the NCT07559097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leptomeningeal Metastasis From Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07559097 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07559097 currently recruiting?
Yes, NCT07559097 is actively recruiting participants. Visit ClinicalTrials.gov or contact Henan Cancer Hospital to inquire about joining.
Where is the NCT07559097 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07559097 clinical trial?
NCT07559097 is sponsored by Henan Cancer Hospital. The trial plans to enroll 14 participants.
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