Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
YTB323 · 2 trials · 3 indications
Incidence of AE's, including Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANs), changes in Vital Signs, Laboratory parameters, ECG, and neurological status qualifying and reported as AEs.
Long term safety follow up
| Arm | Type | Description |
|---|---|---|
| YTB323 | EXPERIMENTAL | YTB323 single intravenous (i.v.) infusion |
| Name | Type | Description |
|---|---|---|
| YTB323 | GENETIC | CAR-T cell suspension for intravenous infusion |
Inclusion Criteria: 1. Confirmed gMG diagnosis supported by the following: * Documented report of positive serology testing for either AChR antibodies or MuSK antibodies at screening AND at least one of the following: * History of abnormal neuromuscular transmission test demonstrated by repe...
YTB323 is an investigational gene therapy being developed for severe, refractory Systemic Lupus Erythematosus (SLE) and Generalized Myasthenia Gravis (gMG). It is currently in Phase 1 clinical trials for these autoimmune conditions, with studies enrolling adult patients aged 18 years and older.
YTB323 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 1 clinical trials to evaluate the safety, efficacy, and cellular kinetics of YTB323 in patients with Systemic Lupus Erythematosus and Generalized Myasthenia Gravis.
YTB323 is in Phase 1 clinical development. It is an investigational gene therapy that has not yet been approved by regulatory authorities. Two Phase 1 trials are ongoing: one for Systemic Lupus Erythematosus and one for Generalized Myasthenia Gravis, with a combined planned enrollment of 36 participants.
YTB323 is being evaluated in two Phase 1 clinical trials. The first, NCT05798117, is an open-label study in severe, refractory Systemic Lupus Erythematosus with 21 participants, active but not recruiting. The second, NCT06704269, is a study in Generalized Myasthenia Gravis with 15 participants, currently recruiting in the United States, France, Japan, and the United Kingdom.
YTB323 is not FDA approved. It is an investigational gene therapy currently in Phase 1 clinical trials for Systemic Lupus Erythematosus and Generalized Myasthenia Gravis. The trials are designed to assess safety, efficacy, and cellular kinetics, and the drug remains in clinical development.