US-based biopharmaceutical company Humanigen has dosed the first participant in a Phase II/III study of lenzilumab for the early treatment of acute Graft versus Host Disease (aGvHD).
The Risk Adapted Therapy in Acute Graft versus Host Disease (RATinG) study is being carried out in partnership with the University of Birmingham’s Cancer Research UK Clinical Trials unit, as well as the British Society of Blood and Marrow Transplantation and IMPACT.
It intends to assess lenzilumab’s efficacy in patients with high-risk aGvHD following allogeneic stem cell transplant (HSCT) and improve their non-relapse mortality.
The study includes two stages and will be conducted at nearly 18 sites across the UK transplant network.
In the first stage, 20 participants are expected to receive lenzilumab ahead of an interim safety, efficacy and feasibility assessment.
Participants in the second stage will be randomised to receive either lenzilumab and steroids or placebo and steroids.
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By GlobalDataOnce all participants have completed at least six months of follow-up, the trial’s second stage will evaluate the primary endpoint of non-relapse mortality.
Christie NHS Foundation Trust Stem Cell Transplantation director Adrian Bloor said: “I am delighted that we have treated our first patient and am grateful to the IMPACT Partnership, Humanigen and to the US MAGIC Consortium for supporting this important study.
“We anticipate that RATinG will be enrolling patients across 18 IMPACT treatment centres in the UK.”
Lenzilumab neutralises the immune signalling of the cytokine granulocyte-macrophage colony-stimulating factor that causes aGvHD.
It is also being used to treat chronic myelomonocytic leukaemia and prevent toxicities associated with CAR-T therapy.
If the trial results are favourable, as decided by an independent data monitoring committee, the trial would proceed to a randomised, double-blind second-stage study enrolling nearly 220 patients.
Based on the 28-day response rate to the first infusion in the initial 150 patients, a second interim analysis is also scheduled to assess futility.
