Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0120 · 8 trials · 13 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 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. |
| 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 |
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 being studied for multiple myeloma, including newly diagnosed multiple myeloma, relapsed or refractory multiple myeloma, and relapsed AL amyloidosis. It is also listed for lupus erythematosus and systemic lupus erythematosus. The drug is in clinical development and is not yet approved.
AZD0120 is a dual-targeted CAR-T therapy directed against B-cell maturation antigen (BCMA) and CD19. This targeting approach is being evaluated in clinical trials for relapsed or refractory multiple myeloma, as described in the DURGA-4 study.
AZD0120 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple myeloma and other conditions.
AZD0120 is in Phase 1 clinical development, with an active Phase 1 trial recruiting participants. Additional Phase 3 trials are listed as recruiting or not yet recruiting, but the drug remains investigational and has not received FDA approval.
AZD0120 is being studied in several trials, including NCT05850234 (DURGA-1, Phase 1 in relapsed/refractory multiple myeloma), NCT07391657 (DURGA-4, Phase 3), NCT07735637 (DURGA-6, Phase 3 in newly diagnosed multiple myeloma), and NCT07764978 (Phase 3 in newly diagnosed multiple myeloma).
Yes, AZD0120 is a dual-targeted CAR-T therapy that targets BCMA and CD19. This is confirmed in the DURGA-4 trial title, which describes AZD0120 as a dual-targeted CAR-T against these antigens, being studied in relapsed or refractory multiple myeloma.