Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as anito-cel
anito-cel (anitocabtagene autoleucel) · 1 trial · 7 indications
Type, incidence, and severity of treatment-emergent adverse events (TEAEs), including DLT(s) and laboratory abnormalities
Evaluate the MTD and establish the RP2D
| Arm | Type | Description |
|---|---|---|
| anito-cel | EXPERIMENTAL | Single dose of anito-cel cells infused intravenously |
| Name | Type | Description |
|---|---|---|
| anito-cel | BIOLOGICAL | Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain |
| Standard Lymphodepletion regimen | DRUG | Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion |
Inclusion Criteria: * Subject must be 18 years of age or older * Must have MGFA clinical classification Grades 2-4A at time of screening * Subject must have clinically active disease and requiring ongoing therapy for GMG * MG-ADL score 6 and QMG score \>10 at screening * GMG specific autoantibodies...
Anitocabtagene autoleucel, known as anito-cel, is an investigational CAR-T cell therapy being developed by Arcellx, Inc. for non-oncology plasma cell-related diseases. It is in Phase 1 clinical development and is being studied in conditions that include muscular diseases, neuromuscular manifestations, and autoimmune diseases such as myasthenia gravis.
Anito-cel is being studied for the treatment of non-oncology plasma cell-related diseases. The Phase 1 trial enrolls adults with muscular diseases, neuromuscular manifestations, autoimmune diseases, autoimmune diseases of the nervous system, myasthenia gravis, and muscle weakness. It is investigational and has not been approved for any use.
Anito-cel is developed by Arcellx, Inc., which trades on the Nasdaq under the ticker ACLX. Arcellx is the sponsor of the Phase 1 study evaluating anitocabtagene autoleucel in non-oncology plasma cell-related diseases.
Anito-cel is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The single Phase 1 study is currently recruiting participants and has an planned enrollment of 30 subjects.
Anito-cel is being evaluated in one active clinical trial, NCT06626919, titled A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases. The study is recruiting in the United States, is uncontrolled, and has a planned enrollment of 30 participants aged 18 years and older.
Yes, anito-cel is the short name for anitocabtagene autoleucel. Both names refer to the same investigational CAR-T cell therapy developed by Arcellx, Inc. for non-oncology plasma cell-related diseases.