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
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.
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