Phase 1 clinical research study expands options for those with solid tumors
(SAN ANTONIO) February 9, 2022 –– NEXT Oncology is offering hope to cancer patients by treating the first patient in Texas with a new cellular immunotherapy. This is the first treatment of its kind at NEXT Oncology and the first clinical study offering the treatment to patients with solid tumors.
This is a Phase I dose-finding study of FT538 (an engineered immune cell which targets cancer cells covered in antibodies) given in combination with cancer targeting antibodies following lymphodepletion in subjects with advanced solid tumors. This type of treatment has shown success previously in blood cancers such as multiple myeloma and leukemias.
“Blood malignancies have similar cell markers, but solid tumors are more variable and harder to identify,” said David Sommerhalder, MD, and Phase I clinical investigator at NEXT Oncology. “Tumor testing helps to identify the cell markers and increase options for treatment.”
The use of FT538 is being researched through a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia and in combination with daratumumab for the treatment of multiple myeloma. In addition, NEXT Oncology is one of three outpatient research sites conducting a multi-dose Phase 1 clinical trial of FT538 in combination with certain monoclonal antibodies targeting EGFR, HER2, and PDL1 for the treatment of solid tumors which express these proteins on their surface.
“Before treatment, patients are given an antibody that matches the cancer cell,” said Dr. Sommerhalder. “The cellular immunotherapy, FT358, is an NK cell (a part of our normal immune system) which is engineered to destroy the cancer cells covered in these antibodies.”
Preclinical data was published in Cell Stem Cell in an online article entitled “Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy.” The study will test three patients in each tumor type group at each dose, and will be testing three different doses, for a total of about 36 patients before moving to expansion or Phase 2 of the study.
Last year, NEXT Oncology opened NEXT-Austin in July and entered a joint venture with Virginia Cancer Specialists in September to form NEXT-Virginia. In November, NEXT Oncology entered into an agreement with the Quirónsalud Hospital Group in Spain to open NEXT-Barcelona and NEXT-Madrid. NEXT Oncology has a relationship with Texas Oncology which is a practice in The US Oncology Network, the largest network of its kind in the United States.
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About NEXT Oncology
NEXT Oncology is dedicated to the development of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them and are looking for their next option. NEXT is partnered with
Texas Oncology, the largest private oncology practice in the United States with more than 400 referring medical oncologists. Texas Oncology is a practice within The US Oncology Network, a network of independent, community-based oncologists in the U.S. This formidable size and reach provide NEXT unprecedented opportunities to transform what has come to be expected from clinical trials of new agents.