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RecruitingInterventionalPhase 1/Phase 2

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

NCT ID: NCT05850234Sponsor: AstraZenecaLast updated: 2026-05-06

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.

Detailed description

Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple myeloma and determine the recommended Phase 2 dose of AZD0120. Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of life parameters in subjects with relapsed/refractory multiple myeloma.

Arms & interventions

  • BiologicalAZD0120

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

Outcome measures

Primary

  • Phase 1b: Adverse Events (AEs)

    The incidence and severity of AEs.

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b: Dose-Limiting Toxicities (DLTs)

    The DLT evaluation period is defined as the first 28 days after infusion.

    Time frame: 28 days

  • Phase 2: Objective Response Rate (ORR)

    Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.

    Time frame: Through study completion, a minimum of 2 years.

Secondary

  • Phase 1b and 2: Complete response rate (CRR)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b and 2: Time to response (TTR)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b: Objective Response Rate (ORR)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months

    Time frame: 12 months

  • Phase 1b and 2: Duration of response (DOR)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b and 2: Progression-free survival (PFS)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 1b and 2: Overall survival (OS)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 2: Adverse Events (AEs)

    Time frame: Through study completion, a minimum of 2 years.

  • Ph1b and 2: Pharmacokinetics - AUC

    Time frame: Through study completion, a minimum of 2 years.

  • Ph1b and 2: Pharmacokinetics - Clast

    Time frame: Through study completion, a minimum of 2 years.

  • Ph1b and 2: Pharmacokinetics - Cmax

    Time frame: Through study completion, a minimum of 2 years.

  • Ph1b and 2: Pharmacokinetics - Tlast

    Time frame: Through study completion, a minimum of 2 years.

  • Ph1b and 2: Pharmacokinetics - Tmax

    Time frame: Through study completion, a minimum of 2 years

  • Ph1b and 2: Humoral Immunogenicity

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 2: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire IL355 (EORTC IL355)

    Time frame: Through study completion, a minimum of 2 years.

  • Phase 2: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC IL356

    Time frame: Through study completion, a minimum of 2 years.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (36)

Research Site

Birmingham, Alabama, 35233

Recruiting

Research Site

Phoenix, Arizona, 85054

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Research Site

La Jolla, California, 92037

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Los Angeles, California, 90095

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San Francisco, California, 94143

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Aurora, Colorado, 80045

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Denver, Colorado, 80218

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Jacksonville, Florida, 32224

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Miami, Florida, 33136

Not Yet Recruiting

Research Site

Tampa, Florida, 33612

Recruiting

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Atlanta, Georgia, 30322

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Chicago, Illinois, 60637

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Iowa City, Iowa, 52242

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Boston, Massachusetts, 02114

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Boston, Massachusetts, 02215

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Ann Arbor, Michigan, 48109

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Detroit, Michigan, 48202

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Minneapolis, Minnesota, 55455

Not Yet Recruiting

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Rochester, Minnesota, 55905

Recruiting

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Omaha, Nebraska, 68198

Withdrawn

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Hackensack, New Jersey, 07601

Withdrawn

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Buffalo, New York, 14203

Not Yet Recruiting

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New York, New York, 10065

Recruiting

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Stony Brook, New York, 11794

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Charlotte, North Carolina, 28204

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Durham, North Carolina, 27705

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Nashville, Tennessee, 37203

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Nashville, Tennessee, 37232

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Austin, Texas, 78704

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Dallas, Texas, 75390

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Houston, Texas, 77030

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Salt Lake City, Utah, 84112

Not Yet Recruiting

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Charlottesville, Virginia, 22908

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Edmonds, Washington, 98026

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Seattle, Washington, 98109

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Research Site

Milwaukee, Wisconsin, 53226

Recruiting