Gene-Modified T-Cell Therapy Targeting Tumor Mutations in Adults With Metastatic Solid Cancers Receiving Pembrolizumab or Alone

What this Trial Is About

Researchers are studying gene transfer therapy using patients own white blood cells genetically engineered to target specific mutations in metastatic solid tumors. This Phase II trial aims to evaluate if these modified T-cells, alone or with pembrolizumab, can shrink tumors in adults whose cancers have not responded to standard treatments. The study includes participants with various metastatic cancers such as gastrointestinal, genitourinary, breast, ovarian, lung, endocrine tumors, and multiple myeloma with solid masses. Participants receive a preparative regimen of cyclophosphamide and fludarabine to reduce immune cells, followed by infusion of their genetically modified T-cells. Those in one group also receive pembrolizumab before and after the cell infusion. Aldesleukin is administered to support the survival of the infused cells. The treatment process includes leukapheresis to collect white blood cells, cell modification in the lab, hospital stays for infusions and recovery, and extended post-treatment drug regimens. Throughout the trial, participants undergo multiple assessments including scans, blood, urine, heart, and lung tests. Safety and tumor response are monitored over time, with primary outcomes measured at 6 and 12 weeks post-infusion and at regular intervals thereafter. Participants are followed for up to two years with ongoing evaluations and medication to prevent infections. The study may last several years, with long-term monitoring to assess treatment effects and safety.

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