NCT05850234 · AstraZeneca
A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
What this study is about
This trial is a phase 1b/2, where both patients and doctors know the treatment given, conducted at multiple hospitals study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
View original scientific description
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
Interventions
BIOLOGICAL
AZD0120
AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Primary outcome measures
Phase 1b: Adverse Events (AEs)
Time frame: Through study completion, a minimum of 2 years.
The incidence and severity of AEs.
Phase 1b: Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
The DLT evaluation period is defined as the first 28 days after infusion.
Phase 2: Objective Response Rate (ORR)
Time frame: Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females ≥18 years of age at the time of consent
- Written informed consent in accordance with federal, local, and institutional guidelines
- Have an ECOG performance status of 0 or 1
- Documented diagnosis of MM per IMWG diagnostic criteria
- Received at least three prior MM treatment lines of therapy
- Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.
- Have documented evidence of progressive disease by the IMWG criteria.
- Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.
- Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP
Exclusion criteria
- Diagnosed or treated for invasive malignancy
Where
- Birmingham, Alabama
- Phoenix, Arizona
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Aurora, Colorado
- Denver, Colorado
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
And 22 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations