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NCT Number: NCT05850234

AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

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.

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Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD0120

Biological

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

Primary outcomes

  1. Phase 1b: Adverse Events (AEs)

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

    The incidence and severity of AEs.

  2. Phase 1b: Dose-Limiting Toxicities (DLTs)

    Time frame: 28 days

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

  3. 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.

Secondary outcomes

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

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

    Defined as the proportion of participants who achieved complete response (CR) or better per International Myeloma Working Group (IMWG) criteria.

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

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

    Defined as the time between date of the initial infusion of AZD0120 and the first efficacy evaluation that the participant has met all criteria for partial response (PR) or better.

  3. Phase 1b: Objective Response Rate (ORR)

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

    Defined as the proportion of participants who achieved PR or better by IMWG response criteria.

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

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

    Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria.

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

    Time frame: 12 months

    Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria at 12 months.

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

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

    Defined among responders as the time from the date of initial documentation of an objective response (overall response of PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

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

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

    Defined as the time from the date of the initial infusion of AZD0120 to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

  8. Phase 1b and 2: Overall survival (OS)

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

    Defined as the time from the date of the initial infusion of AZD0120 to the date of the subject's death.

  9. Phase 2: Adverse Events (AEs)

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

    Further characterization of the safety of AZD0120 by measuring the incidence and severity of AEs.

  10. Ph1b and 2: Pharmacokinetics - AUC

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

    Area under the concentration time-curve of AZD0120 CAR transgene copies.

  11. Ph1b and 2: Pharmacokinetics - Clast

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

    Last quantifiable AZD0120 CAR transgene copies.

  12. Ph1b and 2: Pharmacokinetics - Cmax

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

    Maximum AZD0120 CAR transgene copies.

  13. Ph1b and 2: Pharmacokinetics - Tlast

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

    Time to last quantifiable AZD0120 CAR transgene copies.

  14. Ph1b and 2: Pharmacokinetics - Tmax

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

    Time to reach maximum AZD0120 CAR transgene copies.

  15. Ph1b and 2: Humoral Immunogenicity

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

    Serum samples will be analyzed for anti-drug antibodies (ADA) against AZD0120 using a validated immunoassay. Incidence and prevalence of treatment-emergent ADA will be summarized, with descriptive analyses of associations with pharmacokinetics, efficacy, and safety.

  16. 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.

    Changes from baseline in EORTC IL355 to assess the bone pain and other aspects of function.

  17. 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.

    Changes from baseline in EORTC IL356 to assess the symptomatic toxicities and physical functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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)

Acronym: DURGA-1

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 9, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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