Phase 1b/2 GC012F (AZD012) BCMA CAR T in Relapsed/Refractory Multiple Myeloma

Phase 1b/2 GC012F (AZD012) BCMA CAR T in Relapsed/Refractory Multiple Myeloma

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Purpose of this Study

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.

Who Can Participate?

Eligibility

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.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Phase 1b/2 Study of GC012F (AZD0120), a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma

Principal Investigator

Cristiana Costa
Chase

Protocol Number

PRO00118001

NCT ID

NCT05850234

Phase

I/II

Enrollment Status

Pending Open to Enrollment