Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KYV-101 · 3 trials · 11 indications
Confirmed disability Progression on the EDSS scale. The EDSS scale ranges from 0 to 10 in 0.5- unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Incidence and severity of AEs in Idiopathic inflammatory myopathies
Incidence and severity of AEs in diffuse cutaneous systemic sclerosis
Incidence and severity of AEs in systemic lupus erythematosus nephritis.
Incidence and severity of AEs in ANCA-Associated vasculitis
via revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5
| Arm | Type | Description |
|---|---|---|
| KYV-101 CAR-T cells with lymphodepletion conditioning | EXPERIMENTAL | Dosing with KYV-101 CAR T cells |
| Anti- CD20 mAb | ACTIVE_COMPARATOR | Dosing with anti-CD20 mAb |
| IIM | EXPERIMENTAL | Participants with idiopathic inflammatory myopathy will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101. |
| DCSS | EXPERIMENTAL | Participants with diffuse cutaneous systemic sclerosis will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101. |
| SLE | EXPERIMENTAL | Participants with SLE-related nephritis will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101. |
| AAV | EXPERIMENTAL | Participants with ANCA-associated vasculitis will receive will receive lymphodepleting chemotherapy of cyclophosphamide and fludarabine prior to administration of KYV-101. |
| KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1) | EXPERIMENTAL | Dosing with KYV-101 CAR T cells |
| KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2) | EXPERIMENTAL | Recommended Phase 2 Dose |
| Name | Type | Description |
|---|---|---|
| KYV-101 | BIOLOGICAL | Anti-CD19 CAR-T cell therapy |
| Standard lymphodepletion regimen | DRUG | CYC/FLU |
| Anti-CD20 mAB | DRUG | Anti-CD20 mAB |
| Cyclophosphamide | DRUG | Lymphodepleting chemotherapy of cyclophosphamide (CYC) 300 mg/m2 |
| Fludarabine | DRUG | Lymphodepleting chemotherapy of Fludarabine (FLU) 30 mg/m2 intravenously (IV) |
Key Inclusion Criteria: 1. Subject must have a history of diagnosis of primary progressive or secondary progressive MS. 2. History of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression wi...