Study of Immune Factors Affecting Response and Side Effects of Adoptive Cell Therapy in Solid and Blood Cancers

What this Trial Is About

Researchers are evaluating the immune changes in tumors, blood, and bone marrow following the infusion of somatic cell therapy drugs in patients with solid tumors or hematologic cancers. The study aims to identify specific phenotypic, transcriptional, and epigenetic profiles of immune cells within tumors and correlate these profiles with clinical responses and potential toxicities. This research is designed to explore how different cellular components respond to adoptive cell therapy over time. Participants will undergo several procedures including three tumor biopsies taken at baseline, day 15, and optionally at relapse. Blood samples will be collected seven times at key intervals before and after treatment, including at day -7, day 0, day 3, day 7, day 15, month 3, and at relapse. If bone marrow biopsies or aspirations are done as part of routine care, additional samples will be taken for analysis. During the study, researchers will monitor immune cell changes using spectral flow cytometry and RNA sequencing three months after therapy infusion. They will also evaluate objective response at three months, and track progression-free and overall survival over five years. Safety of biopsy procedures will be assessed from enrollment until 30 days after the last sample. Participants are expected to comply with protocol requirements and provide informed consent, with total participation varying based on individual treatment and follow-up.

An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors