Arovella advances ALA-101 program with CRO appointment for phase 1 trial

Arovella Therapeutics Ltd announced on October 29, 2025, the appointment of SAPRO as its contract research organization (CRO) for the Phase 1 clinical trial of ALA-101. This development follows positive feedback from the FDA during a recent Type D meeting. The Phase 1 trial aims to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ALA-101 in patients with CD19-positive non-Hodgkin's lymphoma and leukemia, with dose escalation anticipated to commence in early 2026.

The first-in-human Phase 1 study will be an open-label, dose escalation and dose expansion trial. Initial clinical sites are expected to be located across Australia and New Zealand. The trial's initial dose escalation phase will evaluate a single dose of ALA-101 to establish the maximum tolerated dose (MTD) for the expansion phase, utilizing a Bayesian design for efficient dose escalation.

ALA-101 consists of CAR19-iNKT cells designed to target CD19, an antigen present on various cancer types. Arovella’s chief executive and managing director, Dr. Michael Baker, expressed excitement about initiating start-up activities and highlighted that the data from this trial will inform not only ALA-101's development but also Arovella’s solid tumor programs.