Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CART-ddBCMA
anitocabtagene-autoleucel · 3 trials · 2 indications
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 |
| ARM 1 | EXPERIMENTAL | Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma |
| 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...
Top 20 of 25 competitors
Anitocabtagene autoleucel is an investigational CAR-T cell therapy being developed for the treatment of multiple myeloma, including relapsed and refractory multiple myeloma. It is being studied in patients whose disease has returned or has not responded to prior therapies. It is not yet approved for commercial use.
Anitocabtagene autoleucel targets BCMA, or B-cell maturation antigen, a protein expressed on multiple myeloma cells. It is an autologous CAR-T therapy, meaning a patient's own T cells are engineered to recognize and attack cells expressing BCMA. This mechanism underlies its investigation in relapsed and refractory multiple myeloma.
Anitocabtagene autoleucel is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is running the clinical development program for the therapy in multiple myeloma, including a Phase 3 study comparing it to standard of care therapy.
Anitocabtagene autoleucel is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program is evaluating the therapy in relapsed and refractory multiple myeloma, building on earlier Phase 1 and Phase 2 studies.
Anitocabtagene autoleucel is being studied in three registered trials. The Phase 3 trial NCT06413498 compares it to standard of care in relapsed and refractory multiple myeloma with 452 participants. The Phase 2 iMMagine-1 trial NCT05396885 enrolled 136 participants, and the Phase 1 trial NCT04155749 enrolled 40 participants.