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.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
