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

NCT04577326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-07-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Roisin O'Cearbhaill, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577326 on ClinicalTrials.gov