We are doing this study to find the most effective, safe dose of an experimental drug called GC012F (the study drug) for adults who have relapsed/refractory multiple myeloma.

Relapsed/Refractory Multiple Myeloma

Adults ages 18+ who:

• Are diagnosed with multiple myeloma
• Have disease that did not respond favorably to treatment or came back after treatment
• Have received at least 3 treatment lines of therapy
• Have received as part of their previous therapy a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody

For more information, contact the study team at jennifer.tichon@duke.edu.

The study will include two parts:

• Part 1: During this part of the study, up to 30 patients will be enrolled in several separate groups, and they will get the study drug to confirm that the dose they receive is safe and tolerable.
• Part 2: During this part of the study, approximately 50 patients will receive the recommended dose of the study drug that was determined to be the most effective during Part 1.

If you choose to join this study, the part in which you participate will depend on when you join. The study team can let you know what part is enrolling before you make your decision.

Everyone who takes part in this study will undergo a procedure called apheresis. During this procedure, a needle will be placed in your arm or a catheter will be placed in a large vein. Your blood will go into a machine. The machine will separate your blood into components. Some of your T cells will be gathered into a collection bag. The rest of your blood will be returned to you through a needle in your other arm or through the catheter. The collected T cells will be used to make the study drug that is later given to you.

Before you get your dose of the study drug, you will undergo a "conditioning treatment." The conditioning treatment consists of cyclophosphamide and fludarabine, which are types of approved chemotherapy for the treatment of some types of cancer. The conditioning treatment is done to help prepare your body to receive the study drug and to help prevent your body from rejecting the study drug.