First-in-Human Trial of an Investigational Cell Therapy for Advanced Gynecologic Cancers Treats First Patient

The first patient was dosed in an early-phase trial evaluating the investigational cell therapy DeTIL-0255 for the treatment of advanced ovarian, cervical and endometrial cancer.

The first patient received treatment in a phase 1 clinical trial evaluating DeTIL-0255 for the treatment of advanced gynecologic malignancies, according to Nurix, the cell therapy’s manufacturer.

The goal of the study is to determine the safety and efficacy of DeTIL-0255, a drug-enhanced tumor-infiltrating lymphocyte (TIL) therapy that inhibits the CBL-B molecule. Since CBL-B negatively affects immune function, inhibiting it allows an anti-tumor response from T cells and other inflammatory molecules.

“Our preclinical models of adoptive T-cell therapy demonstrate that NX-0255 treatment of cells provides improved characteristics that have the potential to increase the success of manufacturing durable cells that can deliver significant anti-tumor effects,” said Dr. Michael T. Lotze, chief cellular therapy officer at Nurix, in a press release.“DeTIL-0255 is an autologous TIL product that is designed to overcome the major limitations of current TIL therapy which include T cell exhaustion post expansion, suboptimal manufacturing success rates, and poor persistence of anti-tumor cells in the patient.”

DeTIL-0255 uses T cells derived from the patient, and will be given via infusion after non-myeloablative (reduced intensity) chemotherapy.

Researchers plan on enrolling approximately 50 patients between the ages of 18 and 70 across multiple cancer centers in the United States. To be eligible, patients must have: recurrent or persistent platinum-resistant epithelial ovarian cancer; recurrent, metastatic or persistent carcinoma of the cervix with progression after treatment with a taxane-containing regimen; or advanced or recurrent endometrial cancer with disease progression after or during second line or greater therapy. All patients must have gone through two or more prior lines of therapy.

Patients must also have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, meaning that their disease minimally interferes with their activities of daily living, as well as adequate organ and bone marrow function, with an absence of growth factors.

The study researchers plan to analyze the following over two years: side effects, deaths, dose-limiting side effects, percentage of patients whose disease shrinks as a result of treatment (known as objective response rate), duration of response, disease control rate, average length of time patients survive after treatment without their disease getting worse (known as progression-free survival) and overall survival.

“The initiation of our first cell therapy study is … the first time targeted protein modulation has been combined with cell therapy, marking the beginning of what we believe will be an important step forward in the treatment of solid tumors,” said Dr. Robert J. Brown, executive vice president of clinical development of Nurix, in the press release.

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