A Phase 1 interventional study of AZD0120 in Multiple Myeloma, sponsored by AstraZeneca. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by AstraZeneca · Phase 1, 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 is the 6th largest by planned enrollment, is the only one that started in 2025, is one of 5 in phase 1, and was the 8th 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, Australia, Brazil and 12 more countries
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. 1 started in 2025.
This study's planned enrollment of 40 is close to 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.
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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 is the 12th largest by planned enrollment, is the only one that started in 2025, is one of 6 in phase 1, and was the 12th 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 an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
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.
Inclusion Criteria:
Age:
Type of Participant and Disease Characteristics:
For NDMM participants:
For Early or Primary Refractory MM (1 or 2 ) participants:
General Exclusion Criteria:
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.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
AZD0120 will be administrated in one infusion
Biological: AZD0120
AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma
Adverse Events (AEs)
Incidence and severity of adverse events (AEs)
Time frame: 2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events (SAEs)
Time frame: 2 years
Dose Limiting Toxicities (DLT)
Incidence of dose limiting toxicities events
Time frame: 28 days
Pharmacokinetic - AUC0-28d
Area under the concentration time-curve of AZD0120 level
Time frame: 0-28 Days
Pharmacokinetic AUC0-3M
Area under the concentration time-curve of AZD0120 level
Time frame: 0 - 3 Months
Pharmacokinetic AUClast
Area under the concentration time-curve of AZD0120 level
Time frame: 2 years
Pharmacokinetic - Cmax
Maximum AZD0120 level
Time frame: 2 years
Pharmacokinetic - Tmax
Time to reach Maximum AZD0120 level
Time frame: 2 years
Pharmacokinetic - Clast
Observed concentration of AZD0120 at last quantifiable concentration
Time frame: 2 years
Pharmacokinetic - Tlast
Time to last quantifiable concentration of AZD0120 level
Time frame: 2 years
Pharmacokinetic - Quantification of CAR transgene levels
Determination of transgene level
Time frame: 2 years
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
Time frame: 2 years
Efficacy - Complete Response Rate (CRR)
Defined as proportion of participants who achieve a CR/sCR response according to the to the IMWG 2016 criteria
Time frame: 2 years
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
Time frame: 9 months
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
Humoral Immunogenicity
Prevalence and incidence ADAs against AZD0120 and the impact on PK, efficacy, and safety, as data allow
Time frame: 2 years
Module 2 Adverse Events (AEs) Maintenance
Incidence and severity of AEs for maintenance following AZD0120 infusion in participants with NDMM
Time frame: 2 years
Module 2 Serious Adverse Events (SAEs) Maintenance
Incidence and severity of SAEs for maintenance following AZD0120 infusion in participants with NDMM
Time frame: 2 years
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
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, Clinical study report
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 rerefer 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 Jul 2025 (actual). Primary completion is estimated for May 2028, 33 months after the start.
Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 33 months is below that.
Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F