Recruiting
Phase 1

GC012F

Sponsor:

AstraZeneca

Code:

NCT07073547

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0120

Study Details

Brief summary:

This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).

Conditions

Multiple Myeloma

Study ID

NCT07073547

Start date

Jul 31, 2025

Status verified date

Jul, 2026

Completion date

May 26, 2028

Anticipated

Primary completion date

May 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age:

  • Males and females ≥18 years of age at the time of consent

Type of Participant and Disease Characteristics:

  • Participant must have documented diagnosis of MM per IMWG diagnostic criteria
  • ECOG performance status of 0 or 1.
  • Adequate organ and bone marrow function.

For NDMM participants:

  • Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
  • For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
  • Classified as high-risk MM

For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:

  • Have received and failed 1 or 2 lines of anti-myeloma therapy
  • Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
  • Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen

General Exclusion Criteria:

  • Have received prior treatment with CAR T therapy directed at any target
  • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
  • Active or history of plasma cell leukemia at the time of screening
  • Seropositive for human immunodeficiency virus (HIV)
  • Active Hepatitis B infection
  • Active Hepatitis C infection
  • Serious underlying medical condition

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD0120

AZD0120 will be administrated in one infusion

Interventions

AZD0120

AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma

Primary outcome measure

  • Adverse Events (AEs) [ Time Frame: 2 years ]
  • Serious Adverse Events (SAEs) [ Time Frame: 2 years ]
  • Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Denver, Colorado, United States, 80218

Research Site

Recruiting

Tampa, Florida, United States, 33612

Research Site

Recruiting

Atlanta, Georgia, United States, 30322

Research Site

Recruiting

Iowa City, Iowa, United States, 52242

Research Site

Recruiting

St Louis, Missouri, United States, 63110

Research Site

Recruiting

New York, New York, United States, 10016

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

AstraZeneca

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Multiple myeloma
  • BCMA
  • CD19
  • CAR-T

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-13.