Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06413498 | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma | PHASE3 | RECRUITING | 450 | — | — | Aug 23, 2024 | Jul 1, 2031 | May 7, 2026 | 124 | United States, Australia +13 |
| NCT05396885 | Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) | PHASE2 | ACTIVE NOT_RECRUITING | 136 | — | — | Jul 15, 2022 | Dec 1, 2026 | Feb 11, 2026 | 18 | United States |
PFS is defined as the time from randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first.
Minimal MRD is defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (\< 1 in 105 nucleated cells per IMWG criteria using NGS) (Kumar 2016). CR/sCR per IMWG criteria is determined by IRC.
ORR Per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee (IRC)
| Arm | Type | Description |
|---|---|---|
| Anitocabtagene Autoleucel | EXPERIMENTAL | Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1. |
| Standard of Care Therapy (SOCT) | ACTIVE_COMPARATOR | Participants will receive the investigator's choice of one of the following therapies: * pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles) * daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles) * carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles) * carfilzomib and dexamethasone (Kd) (28-day cycles) |
| anitocabtagene-autoleucel | EXPERIMENTAL | Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously |
| Name | Type | Description |
|---|---|---|
| Anitocabtagene Autoleucel | DRUG | A single infusion of CAR+ transduced autologous T cells |
| Cyclophosphamide | DRUG | Administered intravenously |
| Fludarabine | DRUG | Administered intravenously |
| Pomalidomide | DRUG | Tablet administered orally |
| Bortezomib | DRUG | Administered intravenously or subcutaneously |
| Dexamethasone | DRUG | Tablet administered orally |
| Daratumumab | DRUG | Administered intravenously or subcutaneously |
| Carfilzomib | DRUG | Administered intravenously |
| anitocabtagene-autoleucel | BIOLOGICAL | Anitocabtagene-autoleucel-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain |
Key Inclusion Criteria: * Documented historical diagnosis of multiple myeloma (MM) * Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD...