The 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 in the ten patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab.

The activity appears to be dose-dependent, with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling.

"We have demonstrated that our nicotinamide-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress, and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumor activity," said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. "

Full data readout of Phase 1 study expected in Q1 2024.

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