The US Food and Drug Administration (FDA) has cleared Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, Investigational New Drug (IND) application for KT501. The clearance allows KT501 to advance into clinical evaluation in the United States.
KT501 is a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager (TCE) being developed for a broad range of B cell–mediated autoimmune diseases. The novel, IgG-like tri-specific antibody binds CD19 and BCMA to reach a wide spectrum of B-cell populations, including plasma cells, while engaging CD3 through a proprietary masking design. This masking platform is intended to maximise potency and limit cytokine release, positioning KT501 to deliver deep, multi-targeted B-cell depletion with an improved safety margin.
The IND clearance is supported by the safety, tolerability, pharmacokinetic and pharmacodynamic data emerging from KT501’s ongoing first-in-human phase 1a study in adults with rheumatoid arthritis (RA), which is being conducted in Australia. KT501 is licensed to Sanofi under a worldwide exclusive agreement announced in March 2026.
The first-in-human phase 1a study (NCT07234773) is an open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered as a single subcutaneous injection in adult participants with RA.
