Testing Tumor Samples for Transgene Levels in Patients Treated with Bristol-Myers Squibb Gene Modified Cell Therapy Who Have Developed a Qualifying Second Primary Cancer

What this Trial Is About

Researchers are evaluating tumor samples from patients who have received gene modified cellular therapies made by Bristol-Myers Squibb. The study focuses on those who have developed a qualifying second primary malignancy after receiving these therapies. This observational research aims to assess the levels of transgenes in the tumor samples to better understand the relationship between the therapy and subsequent cancers. Participants in this study have previously been treated with either idecabtagene vicleucel or lisocabtagene maraleucel, both gene modified cellular therapies manufactured by Bristol-Myers Squibb. Tumor samples from these participants will be tested using in situ hybridization ISH, droplet-based digital Polymerase Chain Reaction ddPCR, and insertion site analysis ISA methods. The study does not involve administering treatments but focuses on testing and analyzing tumor samples. During the study, researchers will review the transgene testing results from the tumor samples collected at baseline. No additional treatments or interventions are administered as part of this study. Participant involvement primarily includes providing access to tumor samples previously collected. The study will monitor the presence and levels of transgenes to contribute to knowledge about the effects of gene modified cellular therapies. This study is sponsored by Bristol-Myers Squibb and is planned to continue through October 2038.

Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy