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Also known as Anitocabtagene Autoleucel
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...
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Anitocabtagene-autoleucel is an investigational cell therapy being developed for the treatment of multiple myeloma, specifically relapsed and refractory multiple myeloma. It is a monoclonal antibody-based cell therapy currently in Phase 3 clinical development. The drug is being studied in patients aged 18 years and older.
Anitocabtagene-autoleucel is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational cell therapy for multiple myeloma.
Anitocabtagene-autoleucel is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial is comparing the drug to standard of care therapy in patients with relapsed or refractory multiple myeloma.
Anitocabtagene-autoleucel is being studied in three clinical trials. NCT06413498 is a Phase 3 trial comparing it to standard of care in relapsed/refractory multiple myeloma. NCT05396885 is a Phase 2 trial (iMMagine-1) in multiple myeloma. NCT04155749 is a Phase 1 trial in relapsed and refractory multiple myeloma.
Yes, anitocabtagene-autoleucel and Anitocabtagene Autoleucel refer to the same drug. The name is sometimes written with or without a hyphen, but both forms identify the same investigational cell therapy being developed by Gilead Sciences for multiple myeloma.
Anitocabtagene-autoleucel is a cell therapy that belongs to the -cel (cell therapy) target class. It is designed to target and treat multiple myeloma by using modified cells to attack cancer cells. The specific molecular target is not disclosed in available information.