Approval Probability
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Also known as KYV-101 (Biological) - 0.33 ×10^8 cells, KYV-101- 0.33 ×10^8 cells, KYV-101 (Biological) - 1 ×10^8 cells, KYV-101- 1 ×10^8 cells, KYV-101 anti-CD19 CAR-T cell therapy
KYV-101 · 7 trials · 13 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.
The primary safety outcome in Phase I variable will be measured as the number of subjects experiencing a cytokine release syndrome (CRS) or an immune cell-associated neurotoxicity syndrome (ICANS) as well as adverse events (AE) and serious adverse events (SAE) due to investigational medical product (IMP) within the first 4 weeks.
The primary efficacy outcome variable of Phase II will be the antineutrophil cytoplasmic antibodies (ANCA) seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV at week 24.
The primary safety outcome variable of Phase II will be measured as adverse events (AE) and serious adverse events (SAE) due to investigational medical product (IMP) throughout the whole study.
Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Immune Cell Associated Neurotoxicity Syn-drome (ICANS) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Adverse Events (AE) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Incidence and grading of severity (graded 0-4) of Serious Adverse Events (SAE) due to IMP within the first 4 weeks after anti-CD19 CAR T cell therapy.
Percentage of subjects with ACPA seroconversion = ACPA level \<20 mU/ml at week 16.
AE due to IMP and rituximab throughout the whole study
SAE due to IMP and rituximab throughout the whole study
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.
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 |
| KYV-101 Treatment | EXPERIMENTAL | Phase 3 |
| Standard of Care | ACTIVE_COMPARATOR | Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks |
| KYV-101, anti-CD19 CAR T-cell immunotherapy. | EXPERIMENTAL | A dosage of 1x10\^8 KYV-101 CAR+ T cells will be administered intravenously as a single infusion. |
| KYV101 | EXPERIMENTAL | Participants in this arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. |
| Rituximab | ACTIVE_COMPARATOR | In the Comparator group patients will receive 2x1 g Rituximab i.v. (Day 0 and Day 14). Retreatment of 1000 mg rituximab i.v. may be initiated at week 24 if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns. A DAS-28-CRP \> 3.2 will be used as a non-binding guidance for the re-treatment decision. |
| 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). |
| 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 |
| Standard of Care Treatment | DRUG | Standard of Care Medications Optional Crossover to receive KYV-101 treatment |
| KYV-101, an autologous fully-human anti-CD19 CAR T-cell immunotherapy | DRUG | A dosage of 1x10\^8 KYV-101 CAR+ T cells will be administered intravenously as a single infusion. |
| KYV101 | DRUG | an autologous fully-human anti-CD19 CAR T-cell immunotherapy |
| Rituximab (active comparator) | DRUG | anti CD20 monoclonal antibody |
| KYV-101 anti-CD19 CAR-T cell therapy | BIOLOGICAL | KYV-101 anti-CD19 CAR-T cell therapy |
| 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. |
| 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 autologous, fully human anti-CD19 CAR T-cell immunotherapy developed by Kyverna Therapeutics, Inc. (ticker: KYTX). It is an investigational cell therapy being studied in immunology indications, including ANCA-associated vasculitis, idiopathic inflammatory myopathies, multiple sclerosis, and myasthenia gravis. KYV-101 is in Phase 1 clinical development.
KYV-101 targets CD19, a protein expressed on B cells. By targeting CD19, KYV-101 is designed to deplete B cells, which are thought to play a role in autoimmune and inflammatory conditions. This mechanism is being evaluated in clinical trials for diseases such as ANCA-associated vasculitis and multiple sclerosis.
KYV-101 is being developed by Kyverna Therapeutics, Inc., a biopharmaceutical company with the ticker symbol KYTX. Kyverna is focused on developing cell therapies for autoimmune and inflammatory diseases.
KYV-101 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 trials are evaluating its safety and potential in various autoimmune conditions.
KYV-101 is being studied in several clinical trials, including NCT06590545 in ANCA-associated vasculitis, NCT06475495 in rheumatoid arthritis, NCT06451159 in progressive multiple sclerosis, and NCT06384976 (KYSA-7) in progressive multiple sclerosis. These trials are in Phase 1 or Phase 2 and are currently active or not yet recruiting.
Yes, KYV-101 is also known as KYV101 and by other names such as KYV-101 (Biological) - 0.33 ×10^8 cells, KYV-101- 0.33 ×10^8 cells, KYV-101 (Biological) - 1 ×10^8 cells, KYV-101- 1 ×10^8 cells, and KYV-101 anti-CD19 CAR-T cell therapy. These all refer to the same investigational therapy.