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Multiple MyelomaPhase 1NCT07073547

A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)

A Phase 1 study testing AZD0120 in people with Multiple Myeloma, run by AstraZeneca at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
AZD0120
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
13 sitesUnited States
Study dates
31 Jul 2025to 26 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 22Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

13 sites in 1 country

United States13 sites, 9 recruiting

  • Research Site

    Atlanta, Georgia, 30322

    Recruiting

  • Research Site

    Charlottesville, Virginia, 22903

    Recruiting

  • Research Site

    Dallas, Texas, 75235

    Withdrawn

  • Research Site

    Denver, Colorado, 80218

    Recruiting

  • Research Site

    Duarte, California, 91010

    Recruiting

  • Research Site

    Houston, Texas, 77030

    Recruiting

  • Research Site

    Iowa City, Iowa, 52242

    Recruiting

  • Research Site

    Nashville, Tennessee, 37203

    Recruiting

  • Research Site

    New York, New York, 10016

    Recruiting

  • Research Site

    Phoenix, Arizona, 85054

    Withdrawn

  • Research Site

    Rochester, Minnesota, 55905

    Withdrawn

  • Research Site

    St Louis, Missouri, 63110

    Recruiting

  • Research Site

    Tampa, Florida, 33612

    Active, not recruiting

Other trials in United States

About this study

Official title: A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)

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).

Read the detailed description

This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.

Being tested
AZD0120
Keywords
Multiple myeloma, BCMA, CD19, CAR-T
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD0120Biological

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

Study groups in NCT07073547
Study groupRoleWhat they receive
AZD0120ExperimentalAZD0120 will be administrated in one infusion
Receives: Biological: AZD0120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Incidence and severity of adverse events (AEs)

    Measured: 2 years

  2. Serious Adverse Events (SAEs)

    Incidence and severity of serious adverse events (SAEs)

    Measured: 2 years

  3. Dose Limiting Toxicities (DLT)

    Incidence of dose limiting toxicities events

    Measured: 28 days

Secondary outcomes (17)

  1. Pharmacokinetic - AUC0-28d

    Area under the concentration time-curve of AZD0120 level

    Measured: 0-28 Days

  2. Pharmacokinetic AUC0-3M

    Area under the concentration time-curve of AZD0120 level

    Measured: 0 - 3 Months

  3. Pharmacokinetic AUClast

    Area under the concentration time-curve of AZD0120 level

    Measured: 2 years

  4. Pharmacokinetic - Cmax

    Maximum AZD0120 level

    Measured: 2 years

  5. Pharmacokinetic - Tmax

    Time to reach Maximum AZD0120 level

    Measured: 2 years

  6. Pharmacokinetic - Clast

    Observed concentration of AZD0120 at last quantifiable concentration

    Measured: 2 years

  7. Pharmacokinetic - Tlast

    Time to last quantifiable concentration of AZD0120 level

    Measured: 2 years

  8. Pharmacokinetic - Quantification of CAR transgene levels

    Determination of transgene level

    Measured: 2 years

  9. Efficacy - Objective Response Rate (ORR)

    Defined as proportion of participants who achieve an overall response of PR or better according to the IMWG 2016 criteria

    Measured: 2 years

  10. Efficacy - Complete Response Rate (CRR)

    Defined as proportion of participants who achieve a CR/sCR response according to the to the IMWG 2016 criteria

    Measured: 2 years

  11. Efficacy - Minimal Residual Disease (MRD) Negative CR Rate at 9 Months (± 3 months)

    Defined as the proportion of participants with CR/sCR and MRD negative status at 9 months (± 3 months) following AZD0120 infusion

    Measured: 9 months

  12. Efficacy - Sustained Minimal Residual Disease (MRD) Negative CR Rate

    Defined as the proportion of participants who achieve CR/sCR and maintain MRD negative status for at least 12 months with no positive MRD detected during that period

    Measured: 2 years

  13. Efficacy - Duration of Response (DOR)

    Defined as the time from first documented confirmed response until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first

    Measured: 2 years

  14. Efficacy - Time to Response (TTR)

    Defined as the time from infusion until the date of first documented objective response, as assessed per IMWG 2016 criteria

    Measured: 2 years

  15. Humoral Immunogenicity

    Prevalence and incidence ADAs against AZD0120 and the impact on PK, efficacy, and safety, as data allow

    Measured: 2 years

  16. Module 2 Adverse Events (AEs) Maintenance

    Incidence and severity of AEs for maintenance following AZD0120 infusion in participants with NDMM

    Measured: 2 years

  17. Module 2 Serious Adverse Events (SAEs) Maintenance

    Incidence and severity of SAEs for maintenance following AZD0120 infusion in participants with NDMM

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study start31 Jul 2025
  3. Primary completion26 May 2028 (estimated)
  4. Study completion26 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
AZD0120 will be administrated in one infusion
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073547
Sponsor's protocol ID
D831EC00001
Status last verified
Sep 2026
First submitted
10 Jul 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD0120 in people with Multiple Myeloma, run by AstraZeneca at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07073547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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Clinical Trial NCT07073547 | AzTrials