AbelZeta Regains Rights to Prizlon-cel, Wins FDA IND Clearance for Bispecific CAR-T in Large B-Cell Lymphoma

AbelZeta Pharma has received FDA clearance of an investigational new drug (IND) application for C-CAR039, also known as prizloncabtagene autoleucel (prizlon-cel), an anti-CD20/CD19 bispecific CAR-T cell therapy for relapsed or refractory (r/r) large B-cell lymphoma (LBCL).¹ The clearance follows AbelZeta's move in July 2026 to reclaim all development, regulatory, manufacturing, commercialization, and out-licensing rights to the asset, unwinding a 2023 licensing deal.¹

Why did the rights return to AbelZeta?

In May 2023, Cellular Biomedicine Group (CBMG) out-licensed global rights outside Greater China for C-CAR039, along with a second CAR-T asset, to Janssen Biotech in a deal worth $245 million upfront.² CBMG changed its corporate name to AbelZeta Pharma in November 2023, after spinning off its stem cell business to focus entirely on its immune cell therapy pipeline.³ Janssen has since discontinued its CD20/CD19 CAR-T development program, returning all rights to AbelZeta.² AbelZeta is now working directly with FDA to finalize protocols for clinical development in two patient populations: third-or-later-line LBCL patients previously treated with CAR-T therapies, and second-line LBCL patients who are CAR-T-naive.¹

What clinical data supports the program?

The renewed US push is backed by long-term data presented at the European Society for Blood and Marrow Transplantation in March 2026. In 48 patients with relapsed or refractory B-cell non-Hodgkin lymphoma treated in AbelZeta's early clinical trials in China, C-CAR039 produced an overall response rate of 91.5% and a complete response rate of 85.1%, with median progression-free survival of 60.1 months at a median follow-up of nearly 54 months.¹ "We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, chairman and chief executive officer of AbelZeta. "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."¹

What happens to patients when CAR-T therapy stops working?

Existing CD19-directed CAR-T therapies have transformed outcomes in relapsed or refractory LBCL, but real-world relapse rates after CAR-T infusion range widely across registries, from roughly 43% to 60% within the first six to twelve months, and prognosis after CAR-T failure remains poor, with median overall survival historically around five to six months.⁴ Sarah Hein, PhD, co-founder and chief executive officer of March Biosciences, described the broader landscape facing patients who relapse after frontline cell therapy in an interview with BioPharm International^©: "Unfortunately, for the T-cell malignancies, what we see is there really is no standard of care for these patients after the disease becomes relapsed or refractory to primary care, and so unfortunately, the prognosis is very, very poor, and there's a number of challenges that have held back the development of cell therapies for these diseases."⁵ Hein's comment addressed T-cell malignancies specifically, but the same unmet-need dynamic drives demand for next-generation options in B-cell disease, where dual-antigen targeting is intended to help address antigen escape, a mechanism of relapse after single-target CD19 CAR-T therapy.

What's next for the program?

A registrational phase 2 trial of C-CAR039 in CAR-T-naive r/r LBCL patients remains ongoing in China.¹ In the US, AbelZeta is finalizing trial protocols with FDA following the IND clearance, with no clinical trial start date yet disclosed.

References

1. AbelZeta regains global rights of C-CAR039 (Prizlon-cel) and receives FDA clearance of IND application in large B-cell lymphoma. News release. AbelZeta Pharma, Inc. Published August 16, 2026. Accessed August 20, 2026.
2. Manalac T. J&J hands lymphoma bispecific CAR T back to AbelZeta. BioSpace. Published August 17, 2026. Accessed August 20, 2026.
3. CBMG Holdings announces name change to AbelZeta Pharma, Inc. News release. AbelZeta Pharma, Inc. Published November 20, 2023. Accessed August 20, 2026.
4. Di Blasi R, Le Gouill S, Bachy E, et al. Outcomes of patients with aggressive B-cell lymphoma after failure of anti-CD19 CAR T-cell therapy: a DESCAR-T analysis. Blood. 2022;140(24):2584-2593. doi:10.1182/blood.2022016945
5. Novel oncology biotherapeutics: CAR-T cell therapy. BioPharm International. Accessed August 20, 2026.