Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD0120 - Regimen 1, AZD0120 - Regimen 2, GC012F, GC012F Injection
AZD0120 · 12 trials · 16 indications
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.
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.
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.
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.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Incidence and severity of DLTs and TEAEs to evaluate the safety of AZD0120 and to confirm the recommended Phase 2 dose (RP2D) in each indication SSc, IIM, or RA
Incidence and severity of Dose Limiting Toxicity (DLT) over 104 weeks following AZD0120 administration.
Incidence and severity of adverse events (AEs)
Incidence and severity of serious adverse events (SAEs)
Incidence of dose limiting toxicities events
The incidence and severity of adverse events (AEs)
To determine the recommended phase 2 dose (RP2D) of AZD0120
Proportion of participants achieving SRI-4 response
The incidence and severity of AEs.
The DLT evaluation period is defined as the first 28 days after infusion.
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
| Arm | Type | Description |
|---|---|---|
| Arm A: AZD0120 | EXPERIMENTAL | AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy. |
| Arm B: Autologous Stem Cell Transplant (ASCT) | ACTIVE_COMPARATOR | ASCT: High-dose melphalan followed by autologous stem cell rescue |
| Arm A: Investigational Arm | EXPERIMENTAL | Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120. |
| Arm B: Control Arm | ACTIVE_COMPARATOR | Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity. |
| Arm A | EXPERIMENTAL | AZD0120 |
| Arm B | ACTIVE_COMPARATOR | 1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd. |
| AZD0120 Regimen 1 | EXPERIMENTAL | Participants will receive an infusion of AZD0120 Regimen 1. |
| AZD0120 Regimen 2 | EXPERIMENTAL | Participants will receive an infusion of AZD0120 Regimen 2. |
| Arm/Group 1: AZD0120 RMS | EXPERIMENTAL | AZD0120 RMS |
| Arm/Group 2: AZD0120 PMS | EXPERIMENTAL | AZD0120 PMS |
| AZD0120 | EXPERIMENTAL | Participants will receive weight-based dose of AZD0120. |
| Name | Type | Description |
|---|---|---|
| AZD0120 | BIOLOGICAL | Arm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion. |
| Cyclophosphamide | DRUG | Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning. |
| Fludarabine | DRUG | Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning. |
| Melphalan (part of ASCT) | DRUG | Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue. |
| Lenalidomide | DRUG | Arm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years. |
| Daratumumab | BIOLOGICAL | Induction, optional bridging and continuous therapy. |
| Dexamethasone | DRUG | Induction, optional bridging and continuous therapy. |
| Isatuximab | BIOLOGICAL | Induction, optional bridging and continuous therapy. |
| Bortezomib | DRUG | Induction therapy. |
| Carfilzomib | DRUG | Carfilzomib |
| Pomalidomide | DRUG | Pomalidomides |
| GC012F | BIOLOGICAL | GC012F is a BCMA/CD19 dual CAR product |
| GC012F Injection | DRUG | The investigational agent, GC012F, is an autologous BCMA/CD19 dual directed CAR product under investigation for the treatment of patients with RRMM, ELMM, SLE, and B NHL. |
| AZD0120 - Regimen 1 | BIOLOGICAL | Regimen 1, infusion of AZD0120 |
| AZD0120 - Regimen 2 | BIOLOGICAL | Regimen 2, infusion of AZD0120 |
Inclusion Criteria: * ≥18 years of age. * Documented diagnosis of NDMM according to IMWG diagnostic criteria. * Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio) *...
AZD0120 is an investigational monoclonal antibody developed by AstraZeneca PLC (ticker AZN). It is being studied in immunology and oncology indications, including systemic lupus erythematosus, multiple sclerosis, multiple myeloma, and relapsed AL amyloidosis. It remains in clinical development and is not described as approved.
AZD0120 is being studied for systemic lupus erythematosus, multiple sclerosis, newly diagnosed and relapsed refractory multiple myeloma, and relapsed AL amyloidosis. Trial activity listed for AZD0120 concentrates on newly diagnosed multiple myeloma, relapsed refractory multiple myeloma, and autoimmune conditions such as systemic sclerosis, idiopathic inflammatory myopathies, and rheumatoid arthritis.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD0120. The company sponsors the clinical studies of AZD0120 listed in registries, including the DURGA-4 and DURGA-6 Phase III trials in multiple myeloma and a Phase I study in autoimmune diseases.
AZD0120 is in Phase 1 development overall, with Phase III trials also recruiting in multiple myeloma. Registry listings show a Phase I study in autoimmune diseases and three recruiting Phase III studies in newly diagnosed and relapsed refractory multiple myeloma. AZD0120 is investigational and not described as FDA approved.
AZD0120 is in recruiting studies including NCT07764978 in newly diagnosed multiple myeloma ineligible for ASCT, NCT07735637 (DURGA-6) comparing consolidation with AZD0120 versus ASCT in transplant eligible patients, NCT07391657 (DURGA-4) in relapsed refractory multiple myeloma, and NCT07295847 in autoimmune diseases.
Yes. AZD0120 is also listed as AZD0120 Regimen 1, AZD0120- Regimen 1, AZD0120 Regimen 2, and AZD0120- Regimen 2. These are alternate listings of the same agent, so searches for any of these names refer to AstraZeneca's AZD0120 program.