AZD0120 for Multiple Myeloma

(DURGA-4 Trial)

Not yet recruiting at 92 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD0120 for people with multiple myeloma, a type of blood cancer. Researchers aim to compare the effectiveness of AZD0120 with current standard treatments. The trial is open to individuals whose multiple myeloma has worsened despite 1 to 3 previous treatments and who have not received specific advanced therapies like CAR-T cell therapy. Participants must show measurable signs of the disease, such as certain protein levels in their blood or urine. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that AZD0120 is likely to be safe for humans?

Research has shown that AZD0120, a new treatment for multiple myeloma, has undergone early testing. These studies focused on safety and found promising results. Patients generally tolerated AZD0120 well.

Some side effects appeared in these studies, but they were mostly mild to moderate. While some people experienced discomfort, it wasn't severe for most. AZD0120 targets specific proteins in cancer cells, potentially allowing it to attack the cancer more directly.

The current trial is in a later phase, indicating that earlier tests demonstrated sufficient safety to proceed. This progression is a positive sign, as treatments typically reach this stage only if deemed safe based on previous testing.12345

Why do researchers think this study treatment might be promising for multiple myeloma?

AZD0120 is unique because it targets multiple myeloma in a novel way, potentially offering a new mechanism of action compared to standard treatments like DKd, DPd, PVd, and Kd. Researchers are excited about AZD0120 because it may provide an option for patients whose cancer doesn't respond to current therapies. This new approach could lead to better outcomes and offer hope for those with resistant forms of the disease.

What evidence suggests that AZD0120 might be an effective treatment for multiple myeloma?

Research has shown that AZD0120, one of the treatments studied in this trial for multiple myeloma, has delivered promising results. In one study, every patient experienced a positive effect, achieving a 100% overall response rate. Impressively, 97% of these patients reached a "stringent complete response," meaning their cancer was undetectable at a very deep level. Another study found a 96% response rate in patients whose multiple myeloma had returned, highlighting the treatment's strong potential. These findings emphasize AZD0120's high effectiveness as a dual-targeted CAR T-cell therapy, which focuses on specific proteins on cancer cells. Participants in this trial may receive AZD0120 or one of the standard regimens as determined by the investigator.13678

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed refractory multiple myeloma (RRMM) who have measurable disease, adequate organ function, and have had 1-3 prior treatments including specific therapies. Not eligible if they've had certain conditions like amyloidosis or plasma cell leukemia, neurological issues, previous BCMA-targeted treatment, CAR-T/NK therapy, T-cell engager therapy or recent stem cell transplantation.

Inclusion Criteria

Documented evidence of measurable disease: Serum M-protein level ≥ 1 g/dL, Urine M-protein level ≥ 200 mg/24h, Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
I am 18 years old or older.
I have been diagnosed with multiple myeloma.
See 5 more

Exclusion Criteria

I have been diagnosed with a specific blood disorder or related condition.
Significant neurological or psychiatric condition
My multiple myeloma did not respond to any previous treatments.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0120 or one of the standard regimens (DKd, DPd, PVd, Kd) for relapsed refractory multiple myeloma

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0120

Trial Overview

The study tests AZD0120 against standard regimens (DKd: daratumumab/carfilzomib/dexamethasone; DPd: daratumumab/pomalidomide/dexamethasone; PVd: pomalidomide/bortezomib/dexamethasone; Kd: carfilzomib/dexamethasone) in RRMM patients. It's a Phase III trial where participants are randomly assigned to receive either the new drug or one of the standard combinations.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BActive Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting ...

Results: As of data cutoff (DCO) on 18 July 2025, a total of 25 pts received infusion of AZD0120 (n=12 DL1; n=13 DL2).

Safety and efficacy of AZD0120, a BCMA/CD19 dual- ...

Results: As of data cutoff (DCO) on 18 July 2025, a total of 25 pts received infusion of AZD0120 (n=12 DL1; n=13 DL2).

BCMA/CD19-Directed CAR T-Cell Therapy Yields 100% ...

GC012F/AZD0120 achieved a 100% overall response rate and 97% stringent complete response in newly diagnosed multiple myeloma patients. The ...

Safety and Efficacy of AZD0120, a BCMA/CD19 Dual- ...

Updated clinical data will be presented. Conclusion. Preliminary phase 1b results demonstrated AZD0120 was well tolerated, with a low incidence of serious AEs, ...

FasTCAR Manufactured BCMAxCD19 CAR T-cell Therapy ...

AZD0120, a dual-targeted CAR T-cell therapy, shows high efficacy in treating relapsed multiple myeloma, achieving a 96% response rate.

NCT07073547 | A Phase I, Open-label, Multicenter Study ...

This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 ...

AstraZeneca advances haematology and cell therapy ...

At ASH, we are sharing meaningful progress with early efficacy and safety data for AZD0120, our first cell therapy, in multiple myeloma, and for ...

AstraZeneca advances hematology and cell therapy ...

At ASH, we are sharing meaningful progress with early efficacy and safety data for AZD0120, our first cell therapy, in multiple myeloma, and for ...