Trial intelligence / Profile preview

EB-MF-CAR-NK-01 in Advanced Pleural and Peritoneal Mesothelioma

NCT07510815Phase 2

Key facts

Status: Recruiting
Start: Mar 2026
Primary completion: Mar 2027
Countries: 1
Sponsor: Biotech Pharmaceutical
Modality: Lymphokine-Activated Killer Cells, CAR-NK Cells

Drugs: EB-MF-CAR-NK-01
Conditions: malignant pleural mesothelioma (MPM)malignant peritoneal mesothelioma (MPM)

Overview

Phase 2, open-label trial of EB-MF-CAR-NK-01 in malignant pleural mesothelioma (MPM) and malignant peritoneal mesothelioma (MPM) (2 cohorts), sponsored by Biotech Pharmaceutical. Primary endpoints: Dose-Limiting Toxicities at 28 days, Treatment-Emergent Adverse Events at 12 months and 1 more. Started Mar 2026; status: recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Pleural Mesothelioma Cohort
Participants receive lymphodepleting chemotherapy followed by locoregional intrapleural infusion of EB-MF-CAR-NK-01.
Peritoneal Mesothelioma Cohort
Participants receive lymphodepleting chemotherapy followed by locoregional intraperitoneal infusion of EB-MF-CAR-NK-01.

Who it enrols

Adults aged 18-75 with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma who have received at least one prior standard systemic regimen. Must have central confirmation of MSLN+ tumor cells and FAP+ stroma, ECOG 0-1, and adequate organ function. Excludes patients with active CNS metastases, uncontrolled infections, or prior MSLN/FAP-directed gene-modified cell therapy.

Endpoints

Primary

Dose-Limiting Toxicities28 days
Treatment-Emergent Adverse Events12 months
Recommended Phase 2 Dose and Schedule6 months

Secondary

Objective Response Rate12 months
Disease Control Rate12 weeks
Duration of Response24 months
Progression-Free Survival24 months
Overall Survival24 months

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