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.

If you choose to take part in this clinical trial, we will do tests to see if you can be in the study. If you can be in the study and choose to take part, we will do tests to see if SEA-BCMA is safe and if it can affect your disease. If your cancer stays the same or gets better, and you don’t have any serious problems, you can keep getting SEA-BCMA until your multiple myeloma gets worse or you have bad side effects.

We will take blood samples for safety and research tests and to check on your disease. These are extra blood samples just for the study. You will also get blood drawn for your normal medical care. A visiting nurse service may come to your home to take some of these blood samples.

How Will The Study Treatment Be Administered?

If your study doctor decides you can be in the study, you can start treatment. SEA-BCMA will be given to you as a liquid into a vein, called an intravenous (IV) “infusion.” The treatment will be administered at the assigned dose every 2 weeks (or every 4 weeks if recommended).

We will treat you on 1 of these treatment schedules:

• Schedule 1: we will give you 1 infusion on the first day and 1 infusion on the 15th day of each 28 day treatment cycle (2 doses every 4 weeks)
• Schedule 2: we will give you an infusion on the first day of each 28 day treatment cycle (1 dose every 4 weeks)

How long will I be in the study?

We will give you SEA-BCMA once every 14 days or once every 28 days in 28-day cycles. If your cancer stays the same or gets better, and you don’t have bad side effects, you can keep getting treated with SEA-BCMA in the study. After you have stopped getting SEA-BCMA, we will ask you to have follow-up visits or phone calls about every 12 weeks or until the study is closed.

If your cancer gets better when you are getting treatment in the study and then gets worse after you stop getting SEA-BCMA, your doctor might say you can get SEA-BCMA again. If this happens, we will do tests to see if you can be treated in the study again.

Additional Trial Information

Phase 1

Enrollment: 225 patients (estimated)