Recruiting
Phase 1
Phase 2

GC012F

Sponsor:

AstraZeneca

Code:

NCT05850234

Conditions

Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0120

Study Details

Brief summary:

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Conditions

Relapsed/Refractory Multiple Myeloma

Study ID

NCT05850234

Start date

Jul 20, 2023

Status verified date

Aug, 2026

Completion date

Jan 25, 2029

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥18 years of age at the time of consent.
  • ECOG performance status of 0 or 1.
  • Documented diagnosis of MM per IMWG diagnostic criteria.
  • Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
  • Have documented evidence of progressive disease per IMWG criteria.
  • Participant must have measurable disease at screening.
  • Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Exclusion Criteria :

  • Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
  • Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
  • Participant has significant cardiac, neurological, or psychiatric conditions.
  • Any other significant medical conditions such as:

  • Serious active or uncontrolled infection
  • Active autoimmune disease or a history of autoimmune disease within 2 years
  • Active plasma cell leukemia at the time of screening
  • Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
  • Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

232 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD0120

AZD0120 will be administered by infusion

Interventions

AZD0120

AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

Primary outcome measure

  • Phase 1b: Adverse Events (AEs) [ Time Frame: Through study completion, a minimum of 2 years. ]
  • Phase 1b: Dose-Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  • Phase 2: Objective Response Rate (ORR) [ Time Frame: Through study completion, a minimum of 2 years. ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Birmingham, Alabama, United States, 35233

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

Recruiting

La Jolla, California, United States, 92037

Research Site

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Los Angeles, California, United States, 90095

Research Site

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San Francisco, California, United States, 94143

Research Site

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Aurora, Colorado, United States, 80045

Research Site

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Denver, Colorado, United States, 80218

Research Site

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Jacksonville, Florida, United States, 32224

Research Site

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Miami, Florida, United States, 33136

Research Site

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Tampa, Florida, United States, 33612

Research Site

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Atlanta, Georgia, United States, 30322

Research Site

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Chicago, Illinois, United States, 60637

Research Site

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Iowa City, Iowa, United States, 52242

Research Site

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Boston, Massachusetts, United States, 02114

Research Site

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Boston, Massachusetts, United States, 02215

Research Site

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Ann Arbor, Michigan, United States, 48109

Research Site

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Detroit, Michigan, United States, 48202

Research Site

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Minneapolis, Minnesota, United States, 55455

Research Site

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Rochester, Minnesota, United States, 55905

Research Site

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New York, New York, United States, 10065

Research Site

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Stony Brook, New York, United States, 11794

Research Site

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Charlotte, North Carolina, United States, 28204

Research Site

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Durham, North Carolina, United States, 27705

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

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Nashville, Tennessee, United States, 37232

Research Site

Recruiting

Austin, Texas, United States, 78704

Research Site

Recruiting

Dallas, Texas, United States, 75390

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Salt Lake City, Utah, United States, 84112

Research Site

Recruiting

Charlottesville, Virginia, United States, 22908

Research Site

Recruiting

Edmonds, Washington, United States, 98026

Research Site

Recruiting

Seattle, Washington, United States, 98109

Research Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

AstraZeneca

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Multiple Myeloma, BCMA, CAR T, CD19, AZD0120

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 2026-08-17.