Cell therapy company Carina Biotech has announced the dosing of the first patient in a Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 for the treatment of adult patients with metastatic colorectal cancer (mCRC).
The company said enrollment in the Phase 1 segment commenced in Australia, with three sites currently activated.
The Phase 1/2a trial is a multi-centre, open-label study in patients with mCRC.
The Phase 1 segment of the trial follows a Bayesian Optimal Interval (BOIN) study design during dose escalation to determine the Recommended Phase 2 Dose (RP2D) level safely and efficiently. A minimum of three subjects per cohort will be enrolled at each dose level.
In the Phase 2a segment of the trial, additional patients will be treated at the RP2D of CNA3103 to further evaluate the safety, anti-tumour activity, and pharmacokinetic and pharmacodynamic properties of CNA3103.
“We are delighted to have dosed the first patient in the Phase 1/2a trial evaluating our LGR5-targeted CAR-T candidate CNA3103. The initiation of our clinical trial in colorectal cancer is a major milestone for Carina. Preclinical studies of CNA3103 have demonstrated highly promising results with complete tumor regression and no tumor recurrence following rechallenge. We look forward to evaluating its profile in patients,” said Carina CEO, Dr Deborah Rathjen.
“A significant unmet need exists in the treatment of colorectal cancer. Colorectal cancer is the second leading cause of cancer deaths among men and women combined, and it is the deadliest form of cancer in Australians aged 25 to 34 years. We are thrilled to play a role in the introduction of a potentially revolutionary and targeted cancer treatment option that harnesses a patient’s own immune system to fight their cancer, which is CAR-T cell therapy.”
Carina’s chief medical officer added, “I look forward to working with my Australian colleagues in the development of CNA3103, a novel, and to our knowledge, first-in-class CAR-T directed against LGR5, a key player in the pathogenesis and dissemination of colorectal cancer. LGR5 is overexpressed in most colorectal cancers and is a marker of stemness, endowing cells with resistance to most forms of chemotherapy. CNA3103 may offer a new way to target this important molecule.”
