Imugene Ltd has cleared the first dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics clinical trial, following Cohort Review Committee (CRC) approval. The OASIS study targets adult patients with advanced or metastatic solid tumours and will now proceed to a higher dose level as part of its planned escalation process.
This first-in-human trial aims to induce CD19 expression in solid tumours using onCARlytics, an oncolytic virus, thereby making the tumours susceptible to CD19-directed immunotherapies.
The OASIS trial is assessing two administration routes—intratumoural (IT) and intravenous (IV)—of onCARlytics, both alone and in combination with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®).
Potential expansion to 10 sites
The trial is being conducted across seven sites in the United States, including City of Hope, MD Anderson Cancer Center, and University of Pittsburgh, with potential expansion to 10 sites. Full recruitment is expected to include 40–50 patients with advanced, treatment-resistant solid tumours.
“CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or gastric do not have a common target on their cell surface, and therefore the aim with onCARlytics is to make available a target for CD19 therapies to treat these solid cancers,” Imugene MD and CEO Leslie Chong said. “As the trial continues to progress and dose escalation is executed, we are eager to learn of the potential impact our treatment is having for patients in need.”
The clinical trial is titled: A Phase I, dose escalation and dose expansion, safety and tolerability study of onCARlytics (CF33-CD19), administered intravenously or intratumorally in combination with blinatumomab in adults with advanced or metastatic solid tumours.
Details are available at clinicaltrials.gov (NCT06063317).