Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GC012F Injection, AZD0120
GC012F · 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) *...
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GC012F is an investigational monoclonal antibody being studied for multiple myeloma, refractory systemic lupus erythematosus, and relapsed/refractory AL amyloidosis. It is currently in Phase 2 clinical development for these conditions.
GC012F is a CAR-T therapy that targets CD19 and BCMA. It is being developed by AstraZeneca PLC (AZN) for the treatment of multiple myeloma, refractory systemic lupus erythematosus, and relapsed/refractory AL amyloidosis.
GC012F is being developed by AstraZeneca PLC, which trades under the ticker AZN. The drug is an investigational monoclonal antibody in Phase 2 clinical development for multiple myeloma, refractory systemic lupus erythematosus, and relapsed/refractory AL amyloidosis.
GC012F is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being studied in clinical trials for multiple myeloma, refractory systemic lupus erythematosus, and relapsed/refractory AL amyloidosis.
GC012F is being studied in three recruiting trials: NCT06235229 for relapsed/refractory multiple myeloma (Phase 1/2, 110 participants), NCT06530849 for refractory systemic lupus erythematosus (Phase 1, 18 participants), and NCT07250269 for relapsed/refractory AL amyloidosis (Phase 1, 9 participants).
Yes, GC012F is also known as GC012F Injection. It is an investigational CAR-T therapy targeting CD19 and BCMA, developed by AstraZeneca PLC (AZN) for multiple myeloma, refractory systemic lupus erythematosus, and relapsed/refractory AL amyloidosis.