Leptomeningeal Disease

10

Review clinical trials related to Leptomeningeal Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Phase 1/2 Study Evaluating the Safety, PK/PD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma

This is a Phase 1/2, multicenter, open-label, dose-escalation and dose-expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), cerebrospinal fluid penetration, and preliminary antitumor activity of orally administered JBI-778, a selective PRMT5 inhibitor, in patients with brain metastases, leptomeningeal disease, or recurrent high-grade glioma. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), followed by expansion cohorts to evaluate preliminary efficacy at the RP2D.

Participants needed: 113
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Jubilant Therapeutics Inc.Updated: Aug 7, 2026
Eligibility criteria

Not listed

Status: Recruiting

Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), in combination with trastuzumab or nivolumab to confirm the highest dose of the study treatment that can be given safely to participants with Breast Cancer (BC) with Leptomeningeal Disease (LMD).

Participants needed: 30
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: H. Lee Moffitt Cancer Center and Research InstituteUpdated: Jul 10, 2026Locations: 1
Eligibility criteria

Histologically or cytologically confirmed diagnosis of BC by ASCO/CAP guidelines... [+11]

Patients with systemic disease are eligible and will be managed as detailed in S... [+20]

Status: Not yet recruiting

ctDNA-Guided Intraventricular Therapy for CNS Malignancies

This prospective, single-center study will evaluate whether cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) testing using the Belay Summit assay can improve the clinical management of patients with malignant gliomas or brain metastases from non-small cell lung cancer (NSCLC) or breast cancer who are suspected of having central nervous system (CNS) disease. Patients undergoing clinically indicated CSF evaluation will receive standard clinical testing, including CSF cytology and the Belay Summit ctDNA assay. Treatment decisions will remain at the discretion of the treating multidisciplinary neuro-oncology team. The primary objective is to evaluate 6-month clinical CNS progression-free survival (cCNS-PFS), with secondary objectives assessing safety and the association between CSF ctDNA dynamics and clinical outcomes. Exploratory proteogenomic analyses will be performed on residual CSF specimens when sufficient sample is available.

Participants needed: 77
Trial details
Age: 18-120Biological sex: AllType: InterventionalSponsor: Alireza MansouriUpdated: Jul 8, 2026
Eligibility criteria

Age ≥ 18 years. [+4]

Age <18 years. [+5]

Status: Recruiting

Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.

Participants needed: 16
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Jul 2, 2026Locations: 3
Eligibility criteria

Adults (male and female) age >18 [+5]

Prior allergy or adverse reaction to methotrexate [+13]

Status: Recruiting

Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Patients with tissue confirmed solid malignancy and standard of care brain MRI w... [+2]

Participants with CSF sampling positive for LMD or MR brain/spine with definitiv... [+2]

Status: Recruiting

Non Interventional German Leptomeningeal Disease Register

The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Hospital TuebingenUpdated: Apr 8, 2026Locations: 7Duration: 5 Years
Eligibility criteria

Patients with leptomeningeal disease [+3]

Lack of informed consent from the patient [+2]

Status: Not yet recruiting

B7-H3.CD28Z.CART in CNS Neoplasms

The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The names of the study investigational therapies involved in this study are: * Fludarabine (a type of chemotherapy) * Cyclophosphamide (a type of chemotherapy) * B7-H3 CAR T cells (a type of cellular therapy)

Participants needed: 70
Trial details
Phase: Phase 1Age: 2-21Biological sex: AllType: InterventionalSponsor: Robbie MajznerUpdated: Feb 5, 2026Locations: 2
Eligibility criteria

Participants must have histologically and/or molecularly confirmed CNS embryonal... [+55]

Tumor with diameter of >5cm in one dimension on T2/FLAIR sequence [+18]

Status: Recruiting

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: UNICANCERUpdated: Nov 18, 2025Locations: 11
Eligibility criteria

Patient must have signed a written informed consent form prior to any trial spec... [+20]

Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the i... [+21]

Status: Recruiting

Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)

To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.

Participants needed: 46
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital TuebingenUpdated: Apr 3, 2025Locations: 9
Eligibility criteria

Patient aged ≥ 18 years at the time of signing the informed consent [+13]

Women during pregnancy and lactation. [+15]

Status: Recruiting

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of ZurichUpdated: May 16, 2024Locations: 3
Eligibility criteria

Adult patients (18 years or more), female or male [+6]

Inability to give informed consent [+1]