NCT04577326

Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma

A Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin With Cell-Intrinsic Checkpoint Inhibition in Patients With Mesothelioma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.

Conditions

• Malignant Pleural Mesothelioma (MPM)

Interventions

Type	Name	Description
DRUG	cyclophosphamide	A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m\^2 will be administered 2-7 days before the infusion.
BIOLOGICAL	CAR T cells	A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. Cohorts of 3 patients will be treated at each dose level, up to a maximum of 3 x 10\^7 T cells/kg or until the MTD has been reached.

Timeline

• Start date: 2020-09-30
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2020-10-06
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study