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anito-cel · 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...
Anito-cel, also known as anitocabtagene autoleucel, is an investigational cell therapy being developed by Arcellx, Inc. (ACLX). It is a monoclonal antibody-based cell therapy currently in Phase 1 clinical development for the treatment of non-oncology plasma cell-related diseases, including certain muscular and autoimmune conditions.
Anito-cel is being studied for the treatment of non-oncology plasma cell-related diseases. The ongoing Phase 1 trial focuses on conditions such as myasthenia gravis, autoimmune diseases of the nervous system, and related muscular and neuromuscular manifestations, including muscle weakness.
Anito-cel is a cell therapy, classified under the -cel (cell tx) target class. It is designed to target plasma cells, which are implicated in certain autoimmune and plasma cell-related diseases. By targeting these cells, anito-cel aims to modulate the immune response in conditions like myasthenia gravis.
Anito-cel is being developed by Arcellx, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACLX. Arcellx is conducting the Phase 1 clinical trial of anito-cel for non-oncology plasma cell-related diseases.
Anito-cel is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial is currently recruiting participants in the United States to evaluate the safety and efficacy of anito-cel in adults with certain autoimmune and muscular diseases.
Anito-cel is being evaluated in a Phase 1 clinical trial with the identifier NCT06626919. This open-label, uncontrolled study is recruiting 30 adult participants in the United States. The trial is investigating anito-cel for the treatment of non-oncology plasma cell-related diseases, including myasthenia gravis and other autoimmune conditions.