AbelZeta Pharma, the clinical-stage biopharmaceutical company with dual centers of excellence in Rockville, Maryland and Shanghai, has regained full global rights to C-CAR039 (prizlon-cel), its anti-CD20/CD19 bispecific CAR-T therapy, and received FDA clearance of an Investigational New Drug application to study it in relapsed or refractory large B-cell lymphoma. The two announcements landed together: AbelZeta reclaimed the rights in July 2026, and the FDA clearance followed the next month, letting the company move directly into planning U.S. trials for an asset it had handed off to a much larger partner three years earlier.
Getting the Drug Back From Janssen
AbelZeta, then operating as Cellular Biomedicine Group, licensed C-CAR039 to Janssen Biotech back in May 2023 as part of a broader collaboration covering multiple CAR-T programs, a deal that came with a $245 million upfront payment plus potential milestones and royalties, with Janssen taking worldwide rights outside Greater China. That arrangement lasted roughly three years before AbelZeta reclaimed all development, regulatory, manufacturing, commercialization, and out-licensing rights to C-CAR039 this July. The company’s own release doesn’t explain why the asset came back, but reclaiming full control of a drug candidate a Big Pharma partner previously held the reins on is now letting AbelZeta chart its own U.S. regulatory path rather than working through Janssen’s development timeline.
What the Drug Has Shown So Far
C-CAR039 targets both CD19 and CD20, two proteins commonly found on the surface of the B-cells that drive non-Hodgkin lymphomas, an approach meant to reduce the chance that a tumor escapes treatment by simply losing one of the two targets. In a study of 48 patients with relapsed or refractory B-cell non-Hodgkin lymphoma, AbelZeta reported 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 at a median follow-up of 53.9 months, alongside what the company describes as a favorable safety profile. CEO Tony (Bizuo) Liu framed the drug’s potential around patients who’ve already failed other CAR-T treatments, a population with few remaining options: “We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio. Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution.”
