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CAR T-cell Therapy

CAR T-cell Therapy for Mesothelioma

Phase 1

Waitlist Available

Led By Roisin O'Cearbhaill, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with peritoneal mesothelioma with pleural involvement are eligible only if there is radiographic and pathologic confirmation of mesothelioma in the pleural cavity and ≥10% of the tumor expresses MSLN by IHC analysis

Chemotherapy, targeted therapy, or therapeutic radiotherapy must be completed at least 14 days before administration of T cells

Must not have

Patients receiving therapy for concurrent active malignancy

Administration of live, attenuated vaccine within 8 weeks before the start of treatment and for 100 days following treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new targeted cancer treatment in people with a specific type of mesothelioma. The goal is to find the safest dose of the treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune reactions due to CAR T-cell activity, effects from cyclophosphamide like nausea and low blood counts, as well as general risks associated with immunotherapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I finished my chemotherapy, targeted therapy, or radiotherapy at least 14 days ago.

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My tumor is mostly epithelioid or mixed and tests positive for MSLN.

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I am 18 years old or older.

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I have undergone at least one treatment regimen.

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My cancer can be measured or seen on tests.

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I finished my cancer treatment at least a week ago.

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I am able to care for myself but may not be able to do active work.

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My diagnosis of mesothelioma has been confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for another cancer.

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I haven't had a live vaccine 8 weeks before or won't for 100 days after starting treatment.

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

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I am taking high doses of corticosteroids every day.

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I have previously undergone CAR T-cell therapy.

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I do not have severe heart or lung conditions, and my oxygen levels are normal without assistance.

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I have untreated brain metastases.

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I have been treated for an autoimmune disease in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD of M28z1XXPD1DNR

Secondary study objectives

overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cyclophosphamide

1994

Completed Phase 3

~8140

CAR T cells

2017

Completed Phase 2

~30