Clinical trial

Clinical trial

CellProtect, autologous ex vivo expanded and activated NK cells with increased tumor killing capacity, is the lead investigational drug candidate of XNK Therapeutics. 

The nature of CellProtect as an autologous NK cell-based therapy product allows it to be used as an adjunct therapy to current clinical praxis and/or in combination with other treatments to potentially enhance the clinical effect. CellProtect has a well-documented safety profile. The product has been granted Orphan Drug Designation (ODD) for the treatment of Multiple myeloma in the European Union. An ODD application has been submitted to the United States Food and Drug Administration (FDA). The product is planned to reach the market via accelerated/conditional approval both in the US and Europe.


ACP-001

First-in-human Phase I/II clinical trial with CellProtect, EudraCT No: 2010-0223330-83, was conducted at the Hematology Center, Karolinska University Hospital, Stockholm, Sweden, in a setting of consolidation treatment following high dose autologous stem cell transplantation in patients newly diagnosed with Multiple myeloma. The clinical study was an open, single-arm, triple escalating dose/patient study with the primary objective of studying the safety and tolerability of the product. The product demonstrated a high degree of safety, and no severe adverse events (SAE) were reported. The secondary objectives included deepening in the response, i.e., further decrease in serum Ig level (M-protein) in patients who did not achieve complete remission and deepening of minimal residual disease (MRD) in patients achieving complete remission. Four out of six patients had measurable disease following autologous SCT. Out of these four patients, all showed objective measurable responses to NK cell infusion in terms of reduction in M-component and/or MRD. The explorative analysis allowed extensive characterization of infused NK cells in patients. The treatment strategy opens for the usage of autologous NK cells in clinical settings.

 


Follow up studies

A Phase II clinical trial combining CellProtect with an anti-cancer antibody is planned for initiation in 2020. Other trial set-ups in different conditions are in progress.


Therapy areas

Multiple myeloma

Multiple myeloma (MM), the company’s first target for CellProtect, is the third most frequent hematological malignancy worldwide. MM treatment has improved over the last two decades with the development and introduction of new agents leading to more effective treatments. Regardless of this, MM remains a fatal disease in the majority of cases. New therapies are needed in this context.

Other areas

CellProtect has ideal properties for being a critical component in tomorrow’s cancer treatment strategies. XNK Therapeutics is currently evaluating different additional targets for CellProtect.