Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KYV-101
KYV101 · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| KYV101 | DRUG | an autologous fully-human anti-CD19 CAR T-cell immunotherapy |
| Rituximab (active comparator) | DRUG | anti CD20 monoclonal antibody |
Main Inclusion Criteria: * Understand and voluntarily sign an informed consent form * Male or female, age ≥ 18 and ≤ 80 years at time of consent * Able to adhere to the study visits and protocol * Fulfilment of the 2010 ACR-EULAR RA classification criteria * ACPA positivity (cut off 20 mU/ml) at sc...
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KYV-101 is an autologous fully-human anti-CD19 CAR T-cell immunotherapy being studied for autoimmune diseases, including primary progressive multiple sclerosis, rheumatoid arthritis, systemic sclerosis, and idiopathic inflammatory myopathies. It is currently in clinical development and is not 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 like multiple sclerosis and systemic sclerosis.
KYV-101 is developed by Kyverna Therapeutics, Inc., a biopharmaceutical company. The company's stock ticker is KYTX. Kyverna is conducting clinical trials to evaluate the safety and efficacy of KYV-101 in patients with various autoimmune diseases.
KYV-101 is in Phase 1 and Phase 2 clinical trials. It has received FDA Fast Track and RMAT (Regenerative Medicine Advanced Therapy) designations. The drug is investigational and has not been approved by the FDA for any indication.
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. A trial for systemic sclerosis, NCT06400303, was terminated. These trials are active but not recruiting.
Yes, KYV-101 is also known as KYV101. It is an autologous fully-human anti-CD19 CAR T-cell immunotherapy. These names refer to the same investigational drug being developed by Kyverna Therapeutics for autoimmune conditions.