Relapsed/Refractory Multiple MyelomaPhase 1/2DURGA-1NCT05850234
AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
A Phase 1/2 study testing AZD0120 in people with Relapsed/Refractory Multiple Myeloma, run by AstraZeneca at 36 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory 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
- 232 participants
- Where
- 36 sitesUnited States
- Study dates
- 20 Jul 2023to 25 Jan 2029
- Phase
- Phase 1/2
- 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
- ≥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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
36 sites in 1 country
United States36 sites, 33 recruiting
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Recruiting
Research Site
Atlanta, Georgia, 30322
- Recruiting
Research Site
Aurora, Colorado, 80045
- Recruiting
Research Site
Austin, Texas, 78704
- Recruiting
Research Site
Birmingham, Alabama, 35233
- Recruiting
Research Site
Boston, Massachusetts, 02114
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Withdrawn
Research Site
Buffalo, New York, 14203
- Recruiting
Research Site
Charlotte, North Carolina, 28204
- Recruiting
Research Site
Charlottesville, Virginia, 22908
- Recruiting
Research Site
Chicago, Illinois, 60637
- Recruiting
Research Site
Dallas, Texas, 75390
- Recruiting
Research Site
Denver, Colorado, 80218
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Durham, North Carolina, 27705
- Recruiting
Research Site
Edmonds, Washington, 98026
- Withdrawn
Research Site
Hackensack, New Jersey, 07601
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Iowa City, Iowa, 52242
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Recruiting
Research Site
La Jolla, California, 92037
- Recruiting
Research Site
Los Angeles, California, 90095
- Recruiting
Research Site
Miami, Florida, 33136
- Recruiting
Research Site
Milwaukee, Wisconsin, 53226
- Recruiting
Research Site
Minneapolis, Minnesota, 55455
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
Nashville, Tennessee, 37232
- Recruiting
Research Site
New York, New York, 10065
- Withdrawn
Research Site
Omaha, Nebraska, 68198
- Recruiting
Research Site
Phoenix, Arizona, 85054
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Recruiting
Research Site
Salt Lake City, Utah, 84112
- Recruiting
Research Site
San Francisco, California, 94143
- Recruiting
Research Site
Seattle, Washington, 98109
- Recruiting
Research Site
Stony Brook, New York, 11794
- Recruiting
Research Site
Tampa, Florida, 33612
About this study
Official 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)
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.
Read the 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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- AZD0120
- Keywords
- Multiple Myeloma, BCMA, CAR T, CD19, AZD0120
- 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 product under investigation for the treatment of participants with RRMM.
| Study group | Role | What they receive |
|---|---|---|
| AZD0120 | Experimental | AZD0120 will be administered by infusion Receives: Biological: AZD0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Adverse Events (AEs)
The incidence and severity of AEs.
Measured: 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.
Measured: 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.
Measured: Through study completion, a minimum of 2 years.
Secondary outcomes (17)
Phase 1b and 2: Complete response rate (CRR)
Defined as the proportion of participants who achieved complete response (CR) or better per International Myeloma Working Group (IMWG) criteria.
Measured: Through study completion, a minimum of 2 years.
Phase 1b and 2: Time to response (TTR)
Defined as the time between date of apheresis and the first efficacy evaluation that the participant has met all criteria for partial response (PR) or better.
Measured: Through study completion, a minimum of 2 years.
Phase 1b: Objective Response Rate (ORR)
Defined as the proportion of participants who achieved PR or better by IMWG response criteria.
Measured: Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria.
Measured: Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria at 12 months.
Measured: 12 months
Phase 1b and 2: Duration of response (DOR)
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.
Measured: Through study completion, a minimum of 2 years.
Phase 1b and 2: Progression-free survival (PFS)
Defined as the time from the date of apheresis to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Measured: Through study completion, a minimum of 2 years.
Phase 1b and 2: Overall survival (OS)
Defined as the time from the date of apheresis to the date of the subject's death.
Measured: Through study completion, a minimum of 2 years.
Phase 2: Adverse Events (AEs)
Further characterization of the safety of AZD0120 by measuring the incidence and severity of AEs.
Measured: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - AUC
Area under the concentration time-curve of AZD0120 CAR transgene copies.
Measured: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Clast
Last quantifiable AZD0120 CAR transgene copies.
Measured: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Cmax
Maximum AZD0120 CAR transgene copies.
Measured: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tlast
Time to last quantifiable AZD0120 CAR transgene copies.
Measured: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tmax
Time to reach maximum AZD0120 CAR transgene copies.
Measured: Through study completion, a minimum of 2 years
Ph1b and 2: Humoral Immunogenicity
Prevalence and incidence of anti-drug antibodies (ADAs) against AZD0120 and the impact on PK, efficacy, and safety, as data allow.
Measured: Through study completion, a minimum of 2 years.
Phase 2: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL355 Bone Pain and Health-Related Quality of Life Scale Scores
Change from baseline in patient-reported bone pain and health-related quality of life, as assessed using the European Organization for Research and Treatment of Cancer Item Library 355 (EORTC IL355), including the QL2 scale.
Measured: Through study completion, a minimum of 2 years.
Phase 2: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL356 Physical Function and Fatigue Subscale Scores
Changes from baseline in patient-reported physical function and fatigue, as assessed using the European Organization for Research and Treatment of Cancer Item Library 356 (EORTC IL356).
Measured: Through study completion, a minimum of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start20 Jul 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion25 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- AZD0120 will be administered by infusion
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850234
- Sponsor's protocol ID
- D8310C00001
- Other IDs
- GC012F-CD19/BCMA-001
- Acronym
- DURGA-1
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2023
- Last updated
- 8 Oct 2026
- Results posted
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05850234
- Acronym / sponsor ID
- DURGA-1 / D8310C00001
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, BCMA, CAR T, CD19, AZD0120
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 25 Jan 2029 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AZD0120 will be administered by infusion
| Arm | Type | Receives |
|---|---|---|
| AZD0120 | Experimental | Biological: AZD0120AZD0120 will be administered by infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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.
Key exclusion criteria (10 listed)
- 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:
- Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0120AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM. | Biological | AZD0120 |
Primary outcome
Phase 1b: Adverse Events (AEs)
Time frame: Through study completion, a minimum of 2 years.
The incidence and severity of AEs.
Phase 1b: Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
The DLT evaluation period is defined as the first 28 days after infusion.
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.
17 secondary outcomes
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: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL355 Bone Pain and Health-Related Quality of Life Scale Scores
Time frame: Through study completion, a minimum of 2 years.
Phase 2: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL356 Physical Function and Fatigue Subscale Scores
Time frame: Through study completion, a minimum of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD0120 in people with Relapsed/Refractory Multiple Myeloma, run by AstraZeneca at 36 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 7 inclusion and 10 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase 1b: Adverse Events (AEs) (time frame: Through study completion, a minimum of 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?
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 8 Oct 2026.