The trial will evaluate the safety and efficacy of the combination regimen in relapsed/refractory diffuse large B cell lymphoma patients. Credit: S_L / Shutterstock.com.

GenFleet Therapeutics has signed a clinical trial collaboration and supply agreement with BeiGene Switzerland to commence a Phase Ib/II clinical trial of GFH009 and BRUKINSA (zanubrutinib) to treat diffuse large B cell lymphoma (DLBCL).

GFH009 is a cyclin-dependent kinase 9 (CDK9) inhibitor of GenFleet while BRUKINSA is a Bruton’s tyrosine kinase (BTK) inhibitor of BeiGene.

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The first patient received the treatment in the study led by Henan Cancer Hospital and Fudan University Shanghai Cancer Center in China.

As per the agreement, GenFleet will carry out the open-label, single-arm, and multicentre study across ten hospitals in China.

The trial aims to evaluate the safety and efficacy of the combination therapy in patients with relapsed/refractory DLBCL.

BeiGene will deliver the clinical drug supplies of BRUKINSA required for the study.

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This study is claimed to be the first combination trial executed by a Chinese biotech company to integrate a CDK9 inhibitor with a BTK inhibitor to treat DLBCL.

GFH009 is currently being assessed in Phase II trials for treating peripheral T-cell lymphoma and acute myeloid leukaemia, in China and the US, respectively.

The US Food and Drug Administration (FDA) granted fast track and orphan drug designations to GFH009 for the treatment of adults with relapsed/refractory peripheral T-cell lymphomas and acute myeloid leukaemia.

The company also signed an exclusive licence agreement with SELLAS Life Sciences in 2022 for all therapeutic and diagnostic uses of GFH009 globally, excluding Greater China.

GenFleet CEO Jiong Lan said: “We are delighted to reach this agreement to move forward the innovative combinational therapy. We appreciate BeiGene’s recognition of GenFleet’s R&D capabilities and GFH009’s clinical potential.

“GFH009 has shown a promising activity in monotherapy trial and BRUKINSA (zanubrutinib) has been approved in scores of markets worldwide; we hope to explore more innovative therapies for relapsed/refractory DLBCL patients with our mutual efforts.”

In October last year, the company dosed the first subject in a Phase Ib/II trial of GFH009 to treat relapsed/refractory peripheral T-cell lymphomas (PTCL).