Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0120 · 6 trials · 11 indications
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 | 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 | CAR-T Cells |
| Daratumumab | DRUG | Daratumumab |
| Carfilzomib | DRUG | Carfilzomib |
| Dexamethasone | DRUG | Dexamethasone |
| Bortezomib | DRUG | Bortezomib |
| Pomalidomide | DRUG | Pomalidomides |
| Cyclophosphamide | DRUG | Lymphodepletion - specified dose prior to receiving AZD0120 |
| Fludarabine | DRUG | Lymphodepletion - specified dose prior to receiving AZD0120 |
Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (...
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