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KYV-101 anti-CD19 CAR-T cell therapy · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| KYV-101 CAR-T cells with lymphodepletion conditioning | EXPERIMENTAL | Dosing with KYV-101 CAR T cells |
| Name | Type | Description |
|---|---|---|
| KYV-101 anti-CD19 CAR-T cell therapy | BIOLOGICAL | KYV-101 anti-CD19 CAR-T cell therapy |
| Standard lymphodepletion regimen | DRUG | Standard lymphodepletion regimen |
Inclusion Criteria: 1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit. 2. Diagnosis of MS according to the 2017 McDonald Criteria. 3. Progressive MS by 2014 Lublin MS phenotypic criteria. 4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least ...
KYV-101 anti-CD19 CAR-T cell therapy is an investigational cell therapy being studied for use in lupus nephritis and multiple sclerosis. It is being developed for refractory lupus nephritis and for non-relapsing and progressive forms of multiple sclerosis, including primary progressive and secondary progressive multiple sclerosis.
KYV-101 anti-CD19 CAR-T cell therapy targets CD19, a protein found on B cells. As a chimeric antigen receptor T-cell therapy, it is designed to direct a patient's T cells to recognize and attack CD19-expressing cells, which are implicated in autoimmune diseases like lupus nephritis and multiple sclerosis.
KYV-101 anti-CD19 CAR-T cell therapy is developed by Kyverna Therapeutics, Inc., a biopharmaceutical company. Kyverna Therapeutics is publicly traded under the ticker symbol KYTX.
KYV-101 anti-CD19 CAR-T cell therapy is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The therapy has received Fast Track designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
KYV-101 anti-CD19 CAR-T cell therapy is being studied in two Phase 1 clinical trials. NCT05938725 (KYSA-1) is studying the therapy in refractory lupus nephritis in the United States, and NCT06138132 is studying it in non-relapsing and progressive forms of multiple sclerosis in the United States.
KYV-101 anti-CD19 CAR-T cell therapy is the investigational therapy being evaluated in the KYSA-1 study. KYSA-1 is the name of a clinical trial (NCT05938725) testing KYV-101 in subjects with refractory lupus nephritis, not an alternative name for the drug itself.