CAR T-cell Therapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

Overseen byRoisin O'Cearbhaill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with mesothelioma who've had at least one treatment regimen, are not on high-dose steroids, and don't have other active cancers or certain heart/lung conditions. They must be in good physical condition (Karnofsky score ≥70%) and have a life expectancy of more than 4 months.

Inclusion Criteria

My mesothelioma affects both the lining of my abdomen and lungs, confirmed by tests.

I can finish palliative radiotherapy 2 days before starting lymphodepletion.

Your blood tests need to show a certain level of white blood cells and platelets, and your liver and kidney function need to be within a certain range.

+13 more

Exclusion Criteria

I have had treatment for blood cancer or lymphoid malignancy in the last 5 years.

I am taking high doses of corticosteroids every day.

I am currently being treated for another cancer.

+9 more

Participant Groups

The trial is testing different doses of MSLN-targeted CAR-T cells to find the safest dose for treating mesothelioma. It's the first time this therapy, which includes an anti-PD1 component, is being used in humans.

1Treatment groups

Experimental Treatment

Group I: Engineered Autologous T CellsExperimental Treatment2 Interventions

Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. 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. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells.