Carina Biotech to present details of planned trial of CAR-T cell therapy candidate

Cell therapy immuno-oncology company Carina Biotech has announced a poster presentation showcasing its planned Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 in patients with metastatic colorectal cancer (mCRC).

The presentation is at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting that will take place in Chicago in June.

“We look forward to sharing the innovative design of our planned Phase 1/2a trial with the oncology community at the upcoming 2023 ASCO,” said CEO Deborah Rathjen. “We are currently activating sites in Australia and anticipate commencing patient dosing before the end of the second quarter.”

The company said the Phase 1/2a clinical trial is designed to enrol up to 44 patients with metastatic disease failing prior lines of chemotherapy and who express LGR5 on their cancer cells.

The Phase 1 segment of up to 24 patients will follow a BOIN (Bayesian Optimal Interval) design, and ascending CAR-T cell doses will be administered to cohorts of three patients each to assess the safety and tolerability of CNA3103 and to determine its optimal dose.

The subsequent Phase 2 segment will enrol 20 patients at the optimal dose, in Australia and the US, to characterize the activity of CNA3103 in terms of anti-tumour response, duration of response and time to disease progression.

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