What's the purpose of this trial?

This trial is testing a monoclonal antibody called SEA-BCMA. Researchers want to know what dose is safest, what side effects patients may have, and if SEA-BCMA will work to treat multiple myeloma.

SEA-BCMA is a type of treatment called a monoclonal antibody. Antibodies are part of your immune system. Usually, they help protect you from getting sick. With SEA-BCMA, we are using an antibody designed to stick to the multiple myeloma cells in your body. The antibody sends a signal to other cells in your immune system that kill the cancer cells. It also stops the multiple myeloma cells from getting a signal that makes them grow. The antibody may also stick to some non-cancer cells in your body.

They are asking you to be in this study because you have multiple myeloma that has come back or did not get better with your last therapy.

This trial is currently open and accepting patients.

What's being studied?

• SEA-BCMA is a monoclonal antibody that targets the B-Cell Maturation Antigen (BCMA) and is made with Sugar Engineered Antibody (SEA) technology. Researchers believe this approach may improve immune response to cancer cells.

What will happen during the trial?

This is a Phase 1b dose exploration and expansion study. The study is evaluating the safety, tolerability and efficacy of SEA-BCMA by itself, and when combined with Dexamethasone.

The dose expansion part of this study is being conducted in two parts, Part B (SEA-BCMA monotherapy) and Part C (SEA-BCMA and Dexamethasone). This trial is open label, which means that both you and the researchers running the study will know what therapies you will receive.

Part B (SEA-BCMA Monotherapy)

This part of the study is evaluating the safety and tolerability of SEA-BCMA when given by itself. There are two phases in this part of the study, induction and maintenance therapy. This part of the study may enroll up to 40 patients.

• Induction Phase – This part of the study will last for two cycles, with each cycle lasting 28 days. Participants will receive SEA-BCMA every week during induction. At the end of the eight weeks, participants may move into the maintenance phase of the study if their myeloma has not progressed.
• Maintenance Phase – This part of the study is also set up in 28 day cycles. Participants will receive SEA-BCMA every two weeks.

Part C (SEA-BCMA and Dexamethasone) 

This part of the study is evaluating the safety and tolerability of SEA-BCMA when combined with Dexamethasone. This part of the study is organized into two groups (cohorts) with different dosing schedules.

• Cohort 1 - This group is organized in 28 day cycles. Patients will receive SEA-BCMA (by intravenous infusion) every two weeks, and Dexamethasone (either a pill or intravenous infusion) weekly.
• Cohort 2 - This group is organized in 28 day cycles. Patients will receive SEA-BCMA (by intravenous infusion) every week for the first two cycles, and Dexamethasone (either a pill or intravenous infusion) weekly. If the participants myeloma has not worsened, they may then receive SEA-BCMA every two weeks, and Dexamethasone (either a pill or intravenous infusion) weekly.

After you have stopped receiving SEA-BCMA, study investigators will ask you to participate in a follow up visit or phone call every 3 months until the study ends.

You can decide to stop being in the study at any time. You can still go to your regular hospital or clinic for treatment after you leave this study.

If you decide to stop treatment with SEA-BCMA, you will still be asked to come back to the hospital or clinic for follow-up tests. You may also be asked to take part in follow-up phone calls and visits.

Additional Trial Information

Phase 1

Enrollment: 185 patients (estimated)