Approval Probability
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Adjusted LOA
ML Risk
Also known as KYV101
KYV-101 · 2 trials · 8 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
| 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. |
| 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...
KYV-101 is an investigational autologous fully-human anti-CD19 CAR T-cell immunotherapy being studied for autoimmune diseases including systemic sclerosis, multiple sclerosis, idiopathic inflammatory myopathies, and rheumatoid arthritis. It is in clinical development and has not been approved by the FDA.
KYV-101 targets CD19, a protein found on B cells. As a CAR T-cell therapy, it is designed to recognize and eliminate CD19-expressing cells, which are implicated in autoimmune diseases. This mechanism is being evaluated in clinical trials for conditions such as systemic sclerosis and multiple sclerosis.
KYV-101 is being developed by Kyverna Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker KYTX. The company is conducting clinical trials to evaluate the therapy in patients with various autoimmune diseases.
KYV-101 is in Phase 1 and Phase 2 clinical trials. It is an investigational therapy, meaning it has not been approved by the FDA. The trials are studying its safety and efficacy in autoimmune conditions such as systemic sclerosis, multiple sclerosis, and rheumatoid arthritis.
KYV-101 is being studied in several trials, including NCT06152172 (CARTIMMUNE) for autoimmune diseases, NCT06384976 (KYSA-7) for progressive multiple sclerosis, and NCT06475495 for rheumatoid arthritis. These trials are active but not recruiting, with enrollment ranging from 13 to 120 participants.
Yes, KYV-101 is also known as KYV101. It is an autologous fully-human anti-CD19 CAR T-cell immunotherapy. The different spellings refer to the same investigational drug being developed by Kyverna Therapeutics for autoimmune diseases.