A Phase II Study of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Targeting Neoantigens in Metastatic Cancer Patients

What this Trial Is About

Researchers are investigating a gene transfer therapy using a patient's own white blood cells genetically engineered to attack specific mutations in metastatic solid cancers that have not responded to standard treatments. This Phase II study aims to determine if these modified cells, alone or combined with pembrolizumab, can shrink tumors in patients with various cancers including gastrointestinal, genitourinary, breast, ovarian, non-small cell lung cancer, endocrine tumors, neuroendocrine tumors, and multiple myeloma with solid masses. Participants receive a preparative regimen involving cyclophosphamide and fludarabine to prepare the body, followed by an infusion of their own T-cells modified to express T-cell receptors targeting their tumor's neoantigens. Some participants also receive pembrolizumab before and after cell infusion. Treatment includes high- or low-dose aldesleukin to support the infused cells. The study involves hospitalization for treatment and recovery, followed by long-term antibiotic and possible antiviral therapy. During the study, participants undergo extensive screening, including tumor biopsies, scans, blood tests, and physical exams. After treatment, researchers monitor tumor response with imaging and clinical assessments at multiple time points up to two years. Safety and tolerance are also evaluated. Participants are followed closely with regular visits to assess treatment effects, manage side effects, and track disease status.

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer