A phase 1 study at the University of Pennsylvania is testing the safety of intravenous and intrapleural administered lentiviral transduced huCART-meso cells with or without lymphodepletion.

Clinical Trial Expectations

This clinical trial will consist of 30 participants. The participants will receive modified CAR T-cells and may or may not receive the drug cyclophosphamide.

Participants will be broken down into criteria of Cohorts 1-4 and Cohort 5. In Cohorts 1-4 each cohort will be given CAR T-cells with or without cyclophosphamide by vein. In Cohort 5, patients will be given CAR-T cells without cyclophosphamide by a pleural catheter.

Components of This Trial
  • Immunotherapy – uses the immune system to fight a patient’s cancer. During this type of therapy, their immune system is either stimulated or is given man-made proteins to attack their cancer cells.
  • Chemotherapy – uses a medication or combination of medications to either stop or slow the growth of a patient’s cancer cells. This type of treatment may affect a patient’s entire body because it attacks both their cancer and healthy cells.

Research has revealed that when chemotherapy and immunotherapy are combined, they work together to destroy any dormant cancer cells. Destroying these cancer cells helps eliminate the chances for cancer to occur again.

Get Help Enrolling in This Trial

The lack of treatment options for mesothelioma relative to those for other cancers make clinical trials an invaluable source of treatment. One of the benefits of this trial is that there has been a great success in treating cancer with CAR T-Cells.

Reasons to get involved in this trial include:
  • Receiving proven life-extending treatment
  • Get treated at a top ranking medical center
  • Get treatment that consists of immunotherapy and chemotherapy




Treating With CAR T-Cells and Cyclophosphamide

CAR T-Cells – is an immunotherapy approach that uses a patient’s immune system to fight their disease. By collecting T cells from a patient’s blood, researchers create CAR T-Cells in a lab until they have a hefty amount. The cells are then infused into the patient. Inside the patient these modified cells begin to multiply and kill off cancer cells.

Cyclophosphamide – is a chemotherapy drug. It is known as an alkylating agent. This drug is most active in the resting phase of cells. It works by damaging the DNA of the cell, which keeps the cell from reproducing. Since alkylating agents damage DNA, it is possible that they could affect the cells of the bone marrow.

Some side effects patients have experienced while taking cyclophosphamide are:

  • Nausea
  • Vomiting
  • Fatigue
  • Mouth sores
  • Hair loss

Another prominent side effect is that a patient may experience low blood counts while taking cyclophosphamide. By having a decrease in red and white blood cells and platelets, this puts a patient more at risk for developing an infection, anemia or bleeding.

Trial Eligibility

Patient Eligibility

  • Confirmed histology of malignant pleural or peritoneal mesothelioma
  • Confirmation of tumor mesothelin expression
  • Failure of standard treatment of chemotherapy

Patient Exclusions

  • Biphasic and sarcomatoid mesothelioma histology
  • Participation in another trial within 4 weeks of enrollment
  • Any pleural or peritoneal effusion that cannot be drained by using standard approaches

When it comes to participating in a clinical trial, it is always best to talk to your doctor and your family and loved ones. If you have any questions about getting connected to this clinical trial, please contact Jenna Campagna.

Location
This clinical trial is occurring at the Hospital of the University of Pennsylvania. This university is located in Philadelphia, Pennsylvania. This hospital is a big part of Penn Medicine’s history. In 1751, it became our nation’s first hospital.

Lead Investigator
The head of this study is Janos L Tanyi, MD, PhD. Dr. Tanyi is an assistant professor of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania. His specialization and clinical expertise is in Gynecologic Oncology.