Gamida Cell has revealed early data in 10 patients with CD20 positive non-Hodgkin lymphoma as part of an ongoing study of natural killer (NK) cell therapy candidate GDA-201.
The multicentre Phase I study is designed to evaluate safety and determine the maximum tolerated dose.
Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients).
Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported.
“We have demonstrated that our nicotinamide (NAM)-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumour activity,” said Ronit Simantov, Chief Medical and Scientific Officer of Gamida Cell. “We are encouraged by the safety and activity observed thus far in our Phase I study of cryopreserved GDA-201, which is consistent with results from the Phase I study of a fresh formulation of GDA-201 conducted at the University of Minnesota.”
The NK cells which comprise GDA-201 use Gamida Cell’s NAM technology, which is designed to enhance and expand cells to enhance functionality and phenotype, increase metabolic fitness and reduce oxidative stress.
These functional qualities were studied in detail in a recent study published in July 2023 in Science Translational Medicine, which showed that NK cells cultured with NAM had increased energy levels, enhanced ability to arrive at and invade tumours, and an ability to efficiently eradicate malignant cells in the harsh conditions of the tumour microenvironment.
Additionally, the publication includes clinical data from 19 non-Hodgkin lymphoma patients who received the fresh formulation of GDA-201 in a Phase I study conducted at the University of Minnesota. GDA-201 exhibited a promising efficacy profile, with an overall response rate of 74% and a complete response rate of 68%.
While GDA-201 cells were detected up to 14 days in patients’ blood, the median duration of response was 16 months (range: 5-36 months), suggesting that GDA-201 treatment may prime an endogenous anti-tumour immune response.