Autologous T cell therapy is a type of cell therapy and cancer treatment method in which immune cells are taken from the patient's body and cultured and processed to activate the cells so resistance to cancer is strengthened. The modified and activated cells are then put back in the body, and when these T cells encounter a cancer cell, the activated cell attaches to the membrane of the cancer cell and injects toxic material, which dissolves or disintegrates the cancer cell. Autologous T cell based therapies may address the risks seen in (CAR) T cell therapies, including severe toxicity and primary tumor resistance.

Monoclonal antibodies use natural human immune system functions to fight cancer. Monoclonal antibodies are laboratory-produced molecules that serve as substitute antibodies to restore, enhance or mimic how the immune system attacks cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than on healthy cells. After monoclonal antibodies are administered to a patient through a vein, these can work in one of several ways, or in a combination of methods including: flagging cancer cells by coating the cells with antibodies, by destroying cancer cell membranes, by blocking cell growth, or by preventing blood vessel development.

Combining both autologous T cell and monoclonal antibody therapy, a first in human, Phase I study of ACTR087 in combination with SEA-BCMA, is now open at the MCW Cancer Center for patients with relapsed or refractory multiple myeloma. The autologous T cell therapy is toxic to cancer cells, and the monoclonal antibody therapy triggers a strengthened and more targeted immune response, providing a potentially powerful dual approach to fighting a patient's cancer.

Want to learn more?

Go to ClinicalTrials.gov(NCT03266692) or contact the study manager Sharon Yim.

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Today, pancreatic adenocarcinoma represents a significant cause of morbidity and mortality. While incidence and mortality are decreasing for other types of cancers, pancreatic cancer rates continue to rise. At this time, the only potential avenue for cure is resection (surgery). That’s why the team at the Medical College of Wisconsin Cancer Center are researching other options for the management of borderline resectable and advanced disease. This early phase study is exploring the efficacy and safety of preoperative radiotherapy or preoperative radiotherapy plus chemotherapy in patients with resectable pancreatic cancers, but also in patients with borderline resectable or locally advanced disease. The study randomizes patients to receive either preoperative 1) Stereotactic Body Radiation Therapy or 2) Conventionally Fractionated Concurrent Chemotherapy and Radiation. These initial trial results should lead to an NCI funded multi-site trial.

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Talk to your doctor about this study, learn more at ClinicalTrials.gov (NCT03704662) or contact the study coordinator Haley Heaviland.

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This study uses exosomal RNA to predict the response to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Exploring if a blood test - a noninvasive "liquid biopsy" - can help predict how prostate cancer patients will respond to ADT, a frequently used therapy, this study will inform an upcoming interventional multi-site trial in the next year.

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Talk to your doctor about this study, learn more at ClinicalTrials.gov (NCT02366494) or contact the study coordinator Jaime Goeldner.

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Few therapies are available for patients with high risk smoldering multiple myeloma (SMM). However, SMM has recently gained greater significance based on studies showing that early and more aggressive therapies can be potentially beneficial to patients. This gives rise to the need to more accurately diagnose and risk-stratify patients with SMM and determine early and ongoing treatment. A new phase II trial at the Medical College of Wisconsin Cancer Center does just that. Called ASCENT, this study is now available to some patients with SMM. ASCENT stands for Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant and is testing a new method of induction, consolidation and maintenance therapy for patients with high risk SMM. This study is funded by the International Myeloma Foundation.

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Talk to your doctor about this study, learn more at ClinicalTrials.gov (NCT03289299) or contact the study coordinator Kimberly Dauss.

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Three new trials mark the first studies at the Medical College of Wisconsin Cancer Center to use tumor infiltrating lymphocytes (TILs). TILs are a type of cell therapy where a patient’s own white blood cells are collected and changed in the lab. Once the prepared cells are infused back into the patient, the modified TILs re-infiltrate the tumor to cause lysis, where tumor cells are disintegrated by the rupture of the cell wall.

The first of these studies (NCT02360579) is assessing the effectiveness and safety of TIL therapy in patients with metastatic melanoma. The second study (NCT03083873) is for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck and is testing the safety, side effects and success of TIL therapy followed by immunotherapy with interleukin-2 (IL-2). IL-2 regulates the activities of a patient’s white blood cells, boosting the immune response. The third trial (NCT03108495) is Phase II, multicenter study to evaluate the efficacy and safety using autologous TIL therapy (LN-145) in patients with recurrent, metastatic, or persistent cervical carcinoma.

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To learn more about these trials, go to ClinicalTrials.gov, or contact the study coordinator Matthew Lasowski.

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For patients whose treatment for relapsed or refractory B cell malignancies ended unsuccessfully, this clinical trial may present new possibilities, and help researchers gain a better understanding of this new frontier in medicine. CAR-T gene therapy adapts the patient’s own immune system to attack cancer cells that it once could not see. We are proud to be working on this first of a kind combination CAR-T therapy that focuses on two different proteins within the cancer cell, CD-19 and CD-20. This trial is also testing a novel in house method of creating the enhanced T cells, to offer patients a potentially faster, safer, and more precise tool to fight this cancer

Want to learn more?

Talk to your doctor about this study, learn more at ClinicalTrials.gov (NCT03019055) or contact the study coordinator Sharon Yim.

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This trial utilizes accelerated partial breast irradiation in a preoperative setting, as opposed to the standard postoperative treatment. The study seeks to understand if this preoperative treatment will improve the toxicity profile of breast conservation therapy.

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For more information, talk to your doctor, learn more at ClinicalTrials.gov NCT02728076) or contact the study coordinator Ebony Carson.

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Gynecology Oncology has several innovative trials currently open, including a study for patients with advanced recurrent ovarian cancer, a patient population with few good options. Sponsored by Merck, this phase II study investigates the efficacy and safety of pembrolizumab, a PD-1 inhibitor that has shown success in treating other cancer types.

Want to learn more?

For more information, talk to your doctor, learn more at ClinicalTrials.gov (NCT02766582) or contact the study coordinator Precious Akinsany.

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Note that this study is now closed to accrual.This National Institutes of Health-funded study was for patients with chronic myelogenous leukemia (CML), a blood cancer which is commonly treated with oral medication called Tyrosine kinase inhibitors (TKIs). The current recommendation for CML patients is to continue TKIs therapy indefinitely, despite high costs and significant side effects that decrease patients' health-related quality of life. This study discontinued TKI therapy in 170 willing and eligible CML patients and monitored them closely for 3 years in order to characterize:

• Factors associated with CML recurrence
• Patient-reported health status changes after TKI discontinuation
• Patient decision making regarding TKI discontinuation with monitoring

This multi-institution study was launched at 15 sites across the nation including the MCW Cancer Center. Previous research in France suggested that some patients were able to discontinue medication and remain in remission, but this was the first study conducted in the United States.

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