Arovella Therapeutics Launches Phase 1 Trial for ALA-101 iNKT Cell Therapy

MT Newswires Live

Oct 29, 2025

Arovella Therapeutics (ASX:ALA) has launched start-up activities for its phase 1 ALA-101 trial, partnering with SAPRO as its contract research organization to progress its invariant Natural Killer T (iNKT) cell therapy platform, according to a Wednesday filing with the Australian bourse.

The dose escalation phase of the trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy to determine the maximum tolerated dose, which the expansion phase will further evaluate, the filing said.

The first-in-human, open-label trial will use dose escalation and expansion to evaluate ALA-101 in CD19-positive non-Hodgkin's lymphoma and leukemia, with initial sites in Australia and New Zealand, per the filing.

The trial will use a Bayesian design to optimize dosing and safety and is awaiting ethics and institutional approvals, the filing added.

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