Adicet Wins FDA Investigational Drug Clearance for NonHodgkin’s Lymphoma Cell Therapy
Adicet has won Investigational New Drug clearance from the FDA for ADI-001, a chimeric antigen receptor (CAR) gamma delta T-cell therapy for nonHodgkin’s lymphoma.
The approval allows the Menlo Park, Calif., company to initiate human trials evaluating the treatment for safety and efficacy.
The phase 1 study plans to enroll up to 80 advanced nonHodgkin’s lymphoma patients across the U.S., with interim clinical data expected sometime next year.
ADI-001 could enable on-demand treatment, selective tumor targeting, and an innate and adaptive anti-tumor immune response, said Adicet President and CEO Chen Schor.