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Also known as KYV-101 (Biological) - 0.33 ×10^8 cells
KYV-101- 0.33 ×10^8 cells · 1 trial · 1 indication
To surmise CNS penetration of CAR-T cells.
* Disease reactivation as defined by the presence of new T2 hyperintense or GAD enhancing lesions on MRI brain at 8 weeks post-infusion of KYV-101. * Incidence of detectable anti-KYV-101 antibodies in peripheral blood. * Incidence of detectable T cells specific to KYV-101 drug product in peripheral blood. * Detectable replication competent lentivirus as measured by surrogate assay (VSV-G qPCR). * Persistence of IgG antibody titers to common vaccine related antigens (varicella, measles, mumps, rubella, tetanus). * Change from baseline in depression/anxiety including C-SSRS.
| Arm | Type | Description |
|---|---|---|
| Dosing Cohort #1: KYV-101 CAR+ T -- 0.33 ×10^8 cells | EXPERIMENTAL | Five participants will be enrolled at the lower dose (0.33 ×10\^8 cells). Once safety and tolerability are adequately assessed, treatment will proceed to the higher dose level. |
| Dosing Cohort #2: KYV-101 CAR+ T -- 1×10^8 cells | EXPERIMENTAL | An additional five participants are planned for enrollment at the higher dose level (1×10\^8 cells). |
| Name | Type | Description |
|---|---|---|
| KYV-101 (Biological) - 0.33 ×10^8 cells | BIOLOGICAL | KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell. |
| KYV-101 (Biological) - 1 ×10^8 cells | BIOLOGICAL | KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell. |
| Chemotherapy: cyclophosphamide (CYC) | DRUG | Participants will receive one 3-day cycle of lymphodepletion with CYC 300 mg/m2 prior to administration of KYV-101. |
| Chemotherapy: fludarabine (FLU) | DRUG | Participants will receive one 3-day cycle of lymphodepletion with FLU 30 mg/m2 prior to administration of KYV-101. |
Inclusion Criteria: 1. Participant must sign a written informed consent form (ICF) prior to any screening procedures. 2. Participant must be 25-70 years of age (inclusive). 3. Clinical diagnosis of MS with evidence of primary or secondary progressive MS based on 2017 International Panel Criteria (T...
KYV-101 is an investigational CD19 CAR T cell therapy being studied for the treatment of progressive multiple sclerosis. It is currently in Phase 1 clinical development for this indication. The therapy is designed to target CD19-positive cells, which are involved in the immune response that contributes to the disease.
KYV-101 targets CD19, a protein found on the surface of B cells. By targeting CD19, the CAR T cell therapy aims to deplete these cells, potentially modulating the immune system's attack on the central nervous system in progressive multiple sclerosis. This mechanism is being evaluated in a Phase 1 clinical trial.
KYV-101 is developed by Kyverna Therapeutics, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of KYV-101 in participants with treatment-refractory progressive multiple sclerosis. Kyverna Therapeutics is publicly traded under the ticker symbol KYTX.
KYV-101 is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of KYV-101 in patients with progressive multiple sclerosis.
KYV-101 is being studied in a Phase 1 clinical trial with the identifier NCT06451159. This trial is titled 'A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis.' The study is active but not recruiting, with an enrollment of 10 participants in the United States.
Yes, KYV-101 is also known as KYV-101 (Biological) - 0.33 ×10^8 cells. This alternative name specifies the dose of the biological product being evaluated in clinical trials. The therapy is a CD19 CAR T cell treatment developed by Kyverna Therapeutics for progressive multiple sclerosis.