The Human Research Ethics Committee (HREC) in Australia has granted clearance for Cullinan Therapeutics to commence an international Phase I clinical trial of CLN-978, a CD19×CD3 bispecific T-cell engager, to treat systemic lupus erythematosus (SLE).
The trial aims to evaluate the safety, pharmacokinetics, and preliminary clinical activity of CLN-978 in SLE patients.
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Cullinan plans to conduct the trial at multiple sites in Australia, as well as internationally.
The latest development in Australia comes after the company submitted an investigational new drug (IND) application with the US Food and Drug Administration seeking approval to commence the trial in the region.
CLN-978 is designed to offer T-cell-directed therapeutic effects, with easy access and convenient dosing, the company noted.
It features a human serum albumin (HSA)-binding domain that prolongs its serum half-life, enabling more convenient subcutaneous administration and potentially reducing toxicity.
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By GlobalDataCLN-978 includes two single-chain variable fragments, targeting CD19 and CD3 on T-cells, and an HSA-binding single-domain antibody.
Developed in-house, CLN-978 is a fully owned asset of Cullinan and holds potential as an off-the-shelf therapeutic option for autoimmune diseases such as SLE and rheumatoid arthritis.
Cullinan Therapeutics chief medical officer Jeffrey Jones said: “We have been focused on rapidly executing our global clinical development strategy for autoimmune diseases, and the approval is an important step to treat patients around the world living with SLE.
“Our investigational candidate, CLN-978, combines the optimal target (CD19) and modality (T-cell engager) for a highly differentiated, potentially best-in-class programme.
“We look forward to working with all our sites, investigators, and patients as we continue to expeditiously progress the development of CLN-978 in Australia and beyond.”
In June this year, Cullinan Therapeutics announced positive topline data from a Phase I/II trial of zipalertinib, after prior treatment with Rybrevant in patients with non-small cell lung cancer (NSCLC).
