A Phase 3 interventional study of AZD0120 and Daratumumab in Newly Diagnosed Multiple Myeloma, sponsored by AstraZeneca. Recruiting at 124 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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Among 11 studies testing Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F in Multiple Myeloma — 7 open to participants now, 7 under way, 3 of them phase 3. Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F · Multiple Myeloma.
Among the 11 studies testing Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F in Multiple Myeloma, this one has the largest planned enrollment, is one of 3 that started in 2026, is one of 3 in phase 3, and was the 10th registered.
3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.
Browse Multiple Myeloma studies →7 of the 11 studies testing Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F in Multiple Myeloma are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Brazil and 15 more countries
Ages 18–130
AstraZeneca · Sites in United States, Australia, Brazil and 12 more countries
Ages 18+
AstraZeneca · Sites in United States
Ages 18+
Gracell Biotechnologies (Shanghai) Co., Ltd. · Sites in China
Ages 18–75
AstraZeneca · Sites in United States
Ages 18+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 3 · Phase 3 3
First in 2020; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 750 is above the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.
Median enrollment 40 across the 11 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 3 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
16 studies in Multiple Myeloma by AstraZeneca: 8 open now, 8 under way, 3 of them phase 3. Of 8 finished, 4 (50%) have results posted.
Among the 16 studies in Multiple Myeloma by AstraZeneca, this one has the largest planned enrollment, is one of 4 that started in 2026, is one of 3 in phase 3, and was the 15th registered.
AstraZeneca’s Multiple Myeloma studies by the year they started, since 2008.
1 of the studies testing Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F in Multiple Myeloma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05850234AstraZenecaAZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1) | 2027-10-01 |
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Among the 11 studies testing Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F in Multiple Myeloma, from their registry updates:
Among AstraZeneca’s 16 in Multiple Myeloma:
This tab as a report to print or save as PDF → With an account.
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.
The primary objective is to demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous IsaRd or DRd in terms of progression-free survival (PFS) according to IMWG 2016 criteria, and as assessed by Blinded Independent Central Review (BICR) and miminal residual disease (MRD) negative complete response (CR) rate at 9 months post-randomisation in participants with NDMM who are ineligible to receive ASCT as initial therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Participant is positive for any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.
Biological: AZD0120 · Biological: Daratumumab · Drug: Dexamethasone · Biological: Isatuximab · Drug: Lenalidomide · Drug: Bortezomib · Drug: Cyclophosphamide · Drug: Fludarabine
Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.
Biological: Daratumumab · Drug: Dexamethasone · Biological: Isatuximab · Drug: Lenalidomide · Drug: Bortezomib
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
Induction, optional bridging and continuous therapy.
Induction, optional bridging and continuous therapy.
Induction, optional bridging and continuous therapy.
Induction, optional bridging and continuous therapy.
Induction therapy.
Lymphodepletion
Lymphodepletion
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
Time frame: Up to 9 years.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Time frame: Up to 9 years.
Complete Response Rate
The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR
Time frame: Up to 9 years.
Overall Survival
Time from randomisation until date of death due to any cause
Time frame: Up to 9 years.
Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria
Adverse Event Incidence
Time frame: Up to 9 years.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
Quantification of circulating CAR-T+ cell levels by measuring CAR transgene in peripheral blood and CK parameters of AZD0120 will be measured to characterise the cellular kinetics of AZD0120 in blood.
Time frame: Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.
Time frame: Up to 9 years.
Patient Reported Outcomes
Change from baseline in bone pain severity measured by the European Organisation for Research and Treatment of Cancer Item Library 469 single bone pain item (EORTC IL469 - score range 0 - 100, with higher scores indicating worse bone pain) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Time frame: Up to 9 years.
Patient Reported Outcomes
Change from baseline in fatigue severity, physical functioning, and global health status/quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 fatigue, physical functioning, and global health status/quality of life scales (EORTC QLQ-C30 - score range 0 to 100; higher scores indicate worse fatigue, better physical functioning, and better general health status/quality of life) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Time frame: Up to 9 years.
Overall Response Rate
Proportion of participants who achieved PR or better according to IMWG 2016 criteria
Time frame: Up to 9 years
Duration of Response
Time from first documented confirmed response (PR or better) until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first.
Time frame: Up to 9 years
Time to Response
Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.
Time frame: Up to 9 years
MRD negative CR rate
Proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy.
Time frame: Up to 9 years
Rate of sustained MRD negative CR
Proportion of participants who have achieved MRD negative status and have a response of CR or sCR
Time frame: Up to 9 years
Progression Free Survival 2 (PFS2)
Time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first
Time frame: Up to 9 years
Not enrolling at this site — choose another above.
Showing the first 100 of 124 sites across 15 countries. Choose a country and city above to see the rest.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jan 2029, 30 months after the start.
Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's planned 30 months is below that.
Counting every sponsor, half of 178 studies reached it within 55 months; a quarter within 34 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F