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Patients with class III or class IV lupus nephritis who have relapsed or unresponsive to prior standard of care treatment will be part of the trial. Credit: Sebastian Kaulitzki / Shutterstock.

Artiva Biotherapeutics has announced dosing of the first subject in the Phase I clinical trial of AlloNK (AB-101), a natural killer (NK) cell therapy candidate, along with monoclonal antibodies for the treatment of lupus nephritis (LN).

A non-genetically modified, allogeneic, cryopreserved natural killer (NK) cell therapy candidate, AlloNK is being developed to boost the activity of B-cell targeting monoclonal antibodies to cause B-cell depletion.

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The multi-centre, open-label trial aims to evaluate the safety and clinical activity of AlloNK plus monoclonal antibodies, rituximab or obinutuzumab in subjects with class III or class IV LN who have relapsed or are unresponsive to prior standard of care treatment.

Participants will be assigned to receive AB-101 as monotherapy or alongside rituximab.

Each patient will undergo at least one treatment cycle of AB-101, followed by health and response assessments. Patients may receive a maximum of two treatment cycles spaced 24 weeks apart.

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Artiva had previously conducted a Phase I/II clinical trial of AlloNK in combination with rituximab in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL).

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The trial showed that all 29 patients achieved non-quantifiable peripheral B-cell levels shortly after starting therapy, indicating a potent B-cell depleting mechanism.

AlloNK has also shown complete responses in B-NHL patients.

Given the similarity of the lymphoid tissues affected in B-NHL and autoimmune diseases, Artiva believes the B-NHL trial data supports the therapeutic mechanism of action for autoimmune diseases such as LN.

Artiva Biotherapeutics CEO Fred Aslan said: “We are excited to bring AlloNK to patients with autoimmune disease. To our knowledge, this is the first time a patient has received an allogeneic NK cell therapy candidate in a US clinical trial for the treatment of an autoimmune disease.

“We are encouraged by the activity of AlloNK in our NHL trial, demonstrating AlloNK’s ability to drive B-cell depletion and helping validate the therapy’s potential mechanism of action.

“Furthermore, our ability to combine AlloNK with CD20, CD19, or CD38 directed monoclonal antibodies gives AlloNK the versatility to target distinct B-cell subpopulations across different autoimmune diseases.”