AbelZeta Reclaims C-CAR039 Rights as FDA Clears US Clinical Trials

The company regained control over the development, manufacturing, and commercialization of C-CAR039—also known as Prizloncabtagene Autoleucel—in July 2026. This move allows AbelZeta to finalize clinical protocols targeting two specific patient groups: those who have previously failed CAR-T treatments and those who are entirely treatment-naïve. The firm is prioritizing the drug's potential to address the significant medical gaps left by existing commercial CAR-T options.

Confidence in the program stems from long-term data presented earlier this year at the European Society for Blood and Marrow Transplantation. In trials involving 48 patients with relapsed or refractory B-cell non-Hodgkin lymphoma, the therapy showed an overall response rate of 91.5% and a complete response rate of 85.1%. With a median progression-free survival of 60.1 months, the therapy demonstrated both durability and a favorable safety profile. CEO Tony Liu stated that the company remains fully committed to accelerating the global development of the asset, leveraging its internal GMP facilities in Rockville and Shanghai to bring the treatment to market.