BMS986453

BMS986453 is an investigational substance that appears in the context of long-term follow-up of people treated with genetically modified T cells. The only registered trial is a Phase 4 study that follows 1,410 adults and children for up to 15 years to monitor long-term safety and persistence of the modified cells.^[1]

What is BMS986453?

BMS986453 is a development code for an investigational substance. The available registry data do not describe its chemical class, molecular structure, or whether it is a small molecule or a protein-based substance. The trial record in which BMS986453 appears is a long-term follow-up protocol for subjects treated with gene-modified T cells, which are cells that have been genetically altered to recognise and attack certain cells in the body.^[1] The substance is not described as an authorised medicine in these records.

How does BMS986453 work?

The registry data do not describe a mechanism of action for BMS986453. The trial in which it appears involves several genetically modified T cell products, including CD19-targeted CAR T cells, dual targeting BCMAxGPRC5D CAR T cells, and GPRC5D-targeted CAR T cells.^[1] BMS986453 is listed among these interventions, but the record does not explain how it works or what molecular target it acts on.

Which conditions is BMS986453 used or studied for?

The trial record does not name a specific condition for BMS986453. It states that the conditions are defined by the parent protocol and that the study enrolls all adult and paediatric subjects who received at least one genetically modified T cell infusion in a previous Celgene sponsored study.^[1] The primary outcomes include overall survival and the proportion of subjects who progressed, for subjects with an original diagnosis of malignancies, which means the underlying conditions are cancers treated with genetically modified T cells.^[1]

How is BMS986453 given?

The registry data do not describe a pharmaceutical form or route of administration for BMS986453. The trial record lists it among interventions that are genetically modified T cell products, which are typically given by infusion, but the record does not state the form or route for BMS986453 specifically.^[1]

What do the clinical trials show?

One trial is registered for BMS986453. It is a Phase 4 long-term follow-up study with 1,410 participants, listed as authorised.^[1] The study does not test a new treatment effect; instead, it follows people who already received genetically modified T cells in a previous Celgene study. The main goals are to assess the risk of delayed adverse events, monitor long-term persistence of the genetically modified T cell drug products, monitor for replication competent lentiviruses, assess long-term efficacy, and describe growth and sexual maturity in people who were under 18 years old at the time of treatment.^[1]

The primary outcomes include safety endpoints such as the incidence of delayed adverse events considered at least possibly related to genetically modified T cell therapy, including neurologic, autoimmune, and hematologic disorders, infections, and hospitalisations. The study also measures persistence of the genetically modified T cell drug products and analysis of vector integration sites in Cohort 1, as well as the incidence of replication competent lentiviruses in Cohort 1. For paediatric participants, physical growth and sexual maturity are assessed. Efficacy endpoints include overall survival and the proportion of subjects who progressed, for subjects with an original diagnosis of malignancies. The timeframe for safety and efficacy assessments is up to 15 years from the last genetically modified T cell infusion. For paediatric participants, assessments continue until they reach Tanner Stage 5. Assessments start 3 months after the last infusion, then continue every 6 months until month 60, and then once a year until the end of study.^[1]

Who can take part in these trials?

The study enrolls all adult and paediatric subjects who received at least one genetically modified T cell infusion in a previous Celgene sponsored study.^[1] The record does not list additional inclusion or exclusion criteria. Participants who were under 18 years old at the time of genetically modified T cell treatment have additional assessments of growth and sexual maturity.^[1]

What side effects are known?

The trial record does not report side effects for BMS986453. It is a long-term follow-up study whose purpose is to detect delayed adverse events, and the primary outcomes include the incidence of delayed adverse events considered at least possibly related to genetically modified T cell therapy, such as neurologic, autoimmune, and hematologic disorders, infections, and hospitalisations.^[1] No results or specific side effect frequencies are provided in the registry data.