FDA Grants RMAT and Fast Track Designations to AbelZeta’s Bispecific CAR-T Prizlon-cel in Large B-Cell Lymphoma

FDA has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to AbelZeta’s prizloncabtagene autoleucel (prizlon-cel), an investigational anti-CD20/CD19 bispecific CAR-T cell therapy, for the treatment of relapsed or refractory (r/r) large B-cell lymphoma (LBCL).¹ The designations support a US development strategy that targets both patients whose disease progressed after an FDA-approved CAR-T therapy and patients earlier in the course of disease.¹

“These dual FDA designations are important milestones for Prizlon-cel and support our strategy to develop it across multiple treatment settings in r/r LBCL,” said Tony Liu, chief executive officer of AbelZeta.¹

What do the designations provide?

RMAT designation offers opportunities for intensive FDA interaction on clinical development, including discussions intended to support efficient development and potential approval.¹ Fast Track designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need, and it may allow more frequent FDA interactions and rolling review of portions of a future Biologics License Application (BLA).¹

Why target both CD19 and CD20?

Prizlon-cel, also known as C-CAR039 and A-CAR039, is designed to recognize two B-cell antigens rather than one.¹ The CAR-T therapies currently approved for LBCL target CD19 alone. Loss or reduction of the target antigen on tumor cells, known as antigen escape, is a recognized cause of relapse after CAR-T treatment.³ Dual targeting of CD19 and CD20 is among the most studied strategies to reduce antigen-loss relapse, although a 2025 review in Molecular Cancer noted there is “no solid evidence” yet that dual targeting is clearly superior to single targeting.³

Early clinical data have been encouraging. In long-term follow-up of AbelZeta’s early trials in China, presented at the European Society for Blood and Marrow Transplantation (EBMT) meeting in March 2026, 48 patients with r/r B-cell non-Hodgkin lymphoma achieved an overall response rate of 91.5% and a complete response rate of 85.1%, with median progression-free survival of 60.1 months after a median follow-up of nearly 54 months.² In an earlier analysis of the same 48 patients, cytokine release syndrome occurred in 93.8%, with Grade 3 or higher events in 2.1%, and immune effector cell-associated neurotoxicity syndrome occurred in 6.3%, with no high-grade cases.⁴

What is the US development plan?

AbelZeta plans to evaluate prizlon-cel in ABZT-121 (NCT07875413), a phase 2 study in patients with r/r LBCL who were previously treated with an FDA-approved, commercially available CAR-T therapy.¹ The company intends to assess whether results from that study could support an accelerated approval pathway in this population, subject to clinical results and future discussions with FDA.¹

In parallel, AbelZeta is developing ABZT-131, a randomized study of prizlon-cel in second-line r/r LBCL designed to evaluate the therapy earlier in treatment and further define its role relative to established CAR-T therapies.¹ “Our near-term development strategy includes patients whose disease has progressed following prior CAR T-cell therapy, a population with substantial unmet medical need,” Liu said.¹ A registrational Phase 2 trial in CAR-T-naive r/r LBCL is also ongoing in China.²

Moving CAR-T therapies into earlier lines of treatment could expand the number of patients who receive them, but autologous products still face practical hurdles. In a BioPharm International® Q&A on advanced therapies, Anna Catalanotto, director of advanced therapy commercial strategy at Cardinal Health, said, “The manufacturing complexities can have a significant impact to patient access to these therapies.” AbelZeta manufactures its CAR-T products in its own good manufacturing practice facilities.¹

How did AbelZeta regain the program?

AbelZeta, formerly Cellular Biomedicine Group, out-licensed rights to C-CAR039 outside Greater China to Janssen Biotech in May 2023, along with a second CAR-T asset, for $245 million upfront.⁵ After Janssen discontinued its CD20/CD19 CAR-T development program, AbelZeta regained all global development, regulatory, manufacturing, and commercialization rights in July 2026, as BioPharm International reported.¹˒² FDA cleared the company’s Investigational New Drug application for prizlon-cel in LBCL in August 2026.¹

What happens next?

The company will advance ABZT-121 and ABZT-131 in the United States. “We look forward to working closely with the FDA as we advance both elements of this development strategy,” Liu said.¹

References

1. AbelZeta receives FDA RMAT and Fast Track designations for Prizlon-cel in relapsed or refractory large B-cell lymphoma. News release. AbelZeta; November 10, 2026. Accessed November 10, 2026.
2. AbelZeta regains global rights of C-CAR039 (prizlon-cel) and receives FDA clearance of IND application in large B-cell lymphoma. News release. AbelZeta; August 16, 2026. Accessed November 10, 2026.
3. Lu Y, Zhao F. Strategies to overcome tumour relapse caused by antigen escape after CAR T therapy. Mol Cancer. 2025;24:126. doi:10.1186/s12943-025-02334-6
4. Tucker N. Prizloncabtagene autoleucel makes US debut in global CD19/CD20 CAR T study for B-cell lymphoma. Blood Cancers Today. Published October 15, 2025. Accessed November 10, 2026.
5. Manalac T. J&J hands lymphoma bispecific CAR T back to AbelZeta. BioSpace. Published August 17, 2026. Accessed August 20, 2026.