Gamida Cell Ltd GMDA released new early data in 10 patients with CD20-positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing Phase 1 study of natural killer (NK) cell therapy candidate GDA-201.
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.
Price Action: GMDA shares are up 6.01% at $0.94 during the premarket session on the last check Tuesday.
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