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A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma

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

NCT05850234•AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Detailed Description

For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F (AZD0120). For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 other than multiple myeloma, except: Malignancy treated with curative intent and with no known active disease present for ≥2 years before enrollment; or
•Adequately treated non-melanoma skin cancer without evidence of disease.
•The following cardiac conditions:
•New York Heart Association (NYHA) stage III or IV congestive heart failure
•Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
•History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
•History of severe non-ischemic cardiomyopathy
•Received either of the following:
•An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).
•An autologous stem cell transplant ≤12 weeks before apheresis
+2 more criteria

Locations (37)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Denver, Colorado, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Tampa, Florida, United States

Key Dates

Start Date

July 20, 2023

Primary Completion Date

August 31, 2027

Completion Date

November 15, 2028

Last Updated

August 6, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed/ Refractory Multiple Myeloma

Interventions

GC012F (AZD0120)

BIOLOGICAL

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma

NCT06791681

Relapsed/ Refractory Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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