In short
BMS-986515 is an investigational gene-modified T cell therapy being studied in a long-term follow-up trial. The trial, NCT03435796, is a Phase 4 study that has enrolled 1,410 participants who previously received at least one genetically modified T cell infusion in a Celgene-sponsored study. The main goal is to monitor delayed side effects and long-term outcomes for up to 15 years after the last infusion.
Key points
- BMS-986515 is an investigational gene-modified T cell therapy.
- The long-term follow-up trial is in Phase 4 and has 1,410 participants.
- The study follows people for up to 15 years after their last genetically modified T cell infusion.
- The trial monitors delayed adverse events, long-term persistence of the cells, and overall survival.
- The study includes both adult and paediatric participants.
- The trial identifier is NCT03435796.
What is BMS-986515?
BMS-986515 is an investigational gene-modified T cell therapy. In the registry data, it appears as one of several genetically modified T cell products that were given to participants in previous Celgene-sponsored studies. The long-term follow-up trial NCT03435796 includes people who received at least one infusion of a genetically modified T cell product, and BMS-986515 is among the interventions listed in that trial record. The substance is still investigational; the trial record does not state that BMS-986515 has a marketing authorisation as a medicine.
How does BMS-986515 work?
The trial record does not describe the exact mechanism of action of BMS-986515. The study is a long-term follow-up protocol for subjects treated with gene-modified T cells, which means the cells have been genetically altered before being given to patients. The follow-up trial monitors the long-term persistence of genetically modified T cell drug products and looks for replication competent lentiviruses, which are a potential safety concern with lentiviral vector-derived products. No further details on the molecular target of BMS-986515 are provided in the registry data.
Which conditions is BMS-986515 used or studied for?
The conditions studied in this trial are defined by the parent protocols, not by the follow-up study itself. The trial record lists several related interventions, including CD19-targeted CAR T cells, BCMA and GPRC5D dual-targeting CAR T cells, and idecabtagene vicleucel, which suggests the underlying conditions include certain blood cancers. The registry data does not name the specific conditions for BMS-986515 itself.
How is BMS-986515 given?
The trial record lists BMS-986515 as a drug given by "other use", with a dose reported as 0 mg, meaning the dose was not reported in the register. The pharmaceutical form and route of administration are not described in the registry data. The parent studies involved genetically modified T cell infusions, so the substance is likely given by infusion, but this is not stated for BMS-986515 specifically.
What do the clinical trials show?
The only trial in the registry data for BMS-986515 is NCT03435796, a Phase 4 long-term follow-up study. It is an interventional study that has enrolled 1,410 participants. The trial is authorised, meaning it is open and recruiting or ongoing. The study includes both adult and paediatric participants who received at least one genetically modified T cell infusion in a previous Celgene-sponsored study.
The primary outcomes measured in this trial are safety endpoints, including 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. The study also measures the persistence of genetically modified T cell drug products and the incidence of replication competent lentiviruses. Efficacy endpoints include overall survival and the proportion of subjects who progressed, but only for subjects with an original diagnosis of malignancy.
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 the study.
What side effects are known?
The registry data does not provide a list of side effects for BMS-986515. The trial is designed to detect delayed adverse events, including neurologic, autoimmune, and hematologic disorders, infections, and hospitalisations, but it does not report which side effects have actually been observed. No supplementary sources with side effect information were provided.