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BCMA/CD19 dual target

CompoundAZD0120

Area under investigation

Multiple myeloma

Scientific PillarCell Therapy

 

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DURGA-4 trial overview

Tumor

Relapsed refractory multiple myeloma 

Trial Identifier

NCT07391657

Phase

III

Regimen

AZD0120; DKd, DPd, PVd or Kd (investigator’s choice) until PD or intolerable toxicity

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Study Design

Inclusion criteria

The key inclusion criteria are – 

  • Aged ≥18 years
  • Documented diagnosis of MM with measurable disease per IMWG
  • 1–3 prior lines (including IMiDs and either PI or anti-CD38)
  • Participants with only 1 prior LOT must have progressed within
    47 mo of SCT or if no transplant then within 42 mo of starting initial therapy
  • ECOG-PS status of 0 or 1
  • Adequate hematology and chemistry laboratory values

 

Reference:

Study NCT07391657. ClinicalTrials.gov website.

Exclusion criteria

The key exclusion criteria are -  

  • Prior CAR-T, CAR-NK or TCE therapy directed at any target
  • Prior allogeneic stem cell transplant
  • Known active or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM
  • Primary refractory MM

SOUNDTRACK-F1 trial overview

DURGA-4 trial overview

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Target Overview

B-cell maturation antigen (BCMA) is universally expressed on malignant plasma cells.1 CD19 is expressed on both multiple myeloma cells and their progenitors2 and is a recognized target for other hematologic malignancies and autoimmune diseases.

Compound Overview

AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy, dual-targeting B-cell maturation antigen (BCMA) and CD19, and manufactured on the novel FasT CAR-T cell platform.3 AZD0120 has been acquired from Gracell Biotechnologies.

Mechanism of Action

  • Mechanism of Action

AZD0120 was formerly named GC012F, and next-generation manufacturing refers to the
FasTCAR platform.

References

1. Tai YT, Anderson KC.  Immunotherapy. 2015;7(11):1187-1199. 2. Boucher K, Parquet N, Widen R, et al. Clin Cancer Res. 2012;18(22):6155-6168. 3. Du J, Fu W, Jiang H, et al. Poster presented at ASCO 2023.

 

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DURGA-4 trial overview

Tumor

Relapsed refractory multiple myeloma 

Trial Identifier

NCT07391657

Phase

III

Regimen

AZD0120; DKd, DPd, PVd or Kd (investigator’s choice) until PD or intolerable toxicity

Visit ct.gov

Study Design

Inclusion criteria

The key inclusion criteria are – 

  • Aged ≥18 years
  • Documented diagnosis of MM with measurable disease per IMWG
  • 1–3 prior lines (including IMiDs and either PI or anti-CD38)
  • Participants with only 1 prior LOT must have progressed within
    47 mo of SCT or if no transplant then within 42 mo of starting initial therapy
  • ECOG-PS status of 0 or 1
  • Adequate hematology and chemistry laboratory values

 

Reference:

Study NCT07391657. ClinicalTrials.gov website.

Exclusion criteria

The key exclusion criteria are -  

  • Prior CAR-T, CAR-NK or TCE therapy directed at any target
  • Prior allogeneic stem cell transplant
  • Known active or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM
  • Primary refractory MM

SOUNDTRACK-F1 trial overview

DURGA-4 trial overview

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Abbreviations

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  • BCMA

    B-cell maturation antigen

  • CAR-T

    chimeric antigen receptor T cell (therapy)

  • CAR-NK

    Chimeric antigen receptor natural killer-cell therapy

  • CD19

    cluster of differentiation 19

  • CNS

    Central nervous system

  • CD38

    Cluster of differentiation 38

  • CRR

    Complete response rate

  • DKd

    Daratumumab, carfilzomib, and dexamethasone

  • DPd

    Daratumumab, pomalidomide, and dexamethasone

  • ECOG-PS

    Eastern Cooperative Oncology Group performance status

  • HLA

    human leukocyte antigen

  • IMWG

    International Myeloma Working Group

  • IMiDs

    Immunomodulatory drugs

  • Kd

    Carfilzomib and dexamethasone

  • LOT

    Line of therapy

  • MM

    multiple myeloma

  • MRD

    Minimal residual disease (often also termed measurable residual disease)

  • NCI

    National Cancer Institute

  • neg

    Negative

  • OS

    Overall survival

  • ORR

    Overall response rate

  • PD

    Progressive disease

  • PFS

    Progression-free survival

  • PI

    Proteasome inhibitor

  • PVd

    Pomalidomide, bortezomib, and dexamethasone

  • SCT

    Stem cell transplantation

  • TCE

    T-cell engager

Some compounds herein refer to selected AstraZeneca pipeline products still under development. AstraZeneca pipeline products are investigational products and, as such, are not approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory agency for the uses under investigation. Information regarding these investigational products should, under no circumstances, be regarded as a recommendation for their use or of their safety or efficacy.

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Veeva ID: Z4-84958 US-109129 DE-92568 Last Updated October 20263/26
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