- Male or female aged 18 years or older with a documented historical diagnosis of multiple myeloma.
- Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-CD38 mAb. A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required.
- Documented evidence of progressive disease by IMWG criteria based on the investigator’s determination on or within 12 months of the last dose of the last regimen.
Detailed eligibility reviewed when participants contact the study team.
This clinical trial is for adults who have relapsed or refractory multiple myeloma (either their disease has come back, or it is no longer responding to their current treatment) and standard therapies available to treat their disease may have limited effectiveness.
The purpose of this study is to find out if the study drug, anito-cel, is safe and effective in treating a participant’s relapsed or refractory multiple myeloma, compared to established standard of care treatment (SOCT). Anito-cel is experimental, meaning it is not approved by the United States Food and Drug Administration (FDA).
There are 2 treatment groups in this study, the Anito-cel Group (experimental group) and the Standard of Care Treatment (SOCT) Group. The study treatment a participant receives will be randomly assigned (like tossing a coin), and they will have a 50% chance of receiving anito-cel or SOCT.
If a participant receives anito-cel, the study drug is made using a type of their own white blood cells, called T-cells. These cells are collected from the participant, changed to target their cancer cells, and given back to them. This study drug is given one time into the vein (intravenously).
The duration of the study may be different for each study participant. This will depend on things such as which study treatment group they are assigned to, screening requirements, and their response to study treatment. Participants in both arms will be followed on study for approximately 4 years after being randomly assigned to a study treatment group.
Because this study involves genetically modified cells and requires long-term follow-up, if a participant receives anito-cel, once they complete their approximate 4 years of follow up on this study, they will be asked to transfer to a separate Long-Term Follow-Up (LTFU) study designed to monitor their health for up to 15 years after Anito-Cel infusion.