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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06626919 | A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases | PHASE1 | RECRUITING | 30 | — | — | Apr 30, 2025 | Apr 1, 2028 | Feb 25, 2026 | 13 | United States |
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...