The Phase I trial will assess the therapy to treat advanced hepatocellular carcinoma. Credit: Nephron / commons.wikimedia.org.

Shanghai Cellular Biopharmaceutical Group has unveiled results from a Phase I trial assessing C-CAR031 for the treatment of advanced hepatocellular carcinoma (HCC).

C-CAR031, an autologous GPC3-directed second generation armoured CAR-T with affinity-tuned single-chain variable fragment (scFv) to improve its safety profile, has been developed on the basis of a new cell therapy designed by AstraZeneca.

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Early findings from the first-in-human (FIH) trial showed that C-CAR031 was so far well tolerated with significant anti-tumour activity and objective responses in various patients.

The types of patients included three with confirmed partial responses, two with stable disease and one with progressive disease as per RECIST v1.1 and mRECIST criteria.  

The clinical responses of the patients who attained partial responses are currently going on until the data cut-off date.

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As on 2 March 2023, seven patients were treated with two dose levels of C-CAR031.

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The median number of prior lines of therapies was four, with 77 days of median follow-up.

Satisfactory safety profile was reported at evaluated dose levels of the trial. 

The results also showed that 86% patients had Gr1/2 cytokine release syndrome (CRS). No dose limiting toxicities (DLT) or immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

C-CAR031 demonstrated a solid cellular kinetic profile.

Shanghai is currently conducting a trial at The First Affiliated Hospital, Zhejiang University School of Medicine in Hangzhou, China.

The trial aims to examine the feasibility, safety and initial efficacy of C-CAR301 in the targeted patients.