Prizlon-cel Earns FDA RMAT and Fast Track Designations in Relapsed LBCL

The FDA has granted regenerative medicine advanced therapy (RMAT) and fast track designations to prizloncabtagene autoleucel (prizlon-cel; A-CAR039), an investigational anti-CD20/CD19 bispecific chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), according to a news release from the developer, AbelZeta.¹ Both designations were granted under the agent’s investigational new drug (IND) application.

RMAT designation allows for intensive FDA interaction on clinical development and potential approval, whereas fast track designation is intended to expedite the development and review of therapies for serious conditions with unmet needs and may allow rolling review of portions of a future biologics license application.

“These dual FDA designations are important milestones for [prizlon-cel],” said Tony Liu, chief executive officer of AbelZeta, in the news release.¹

What is prizlon-cel and how does it work?

Prizlon-cel, also known as C-CAR039, is designed to recognize 2 B-cell antigens, CD19 and CD20. Currently approved CAR T-cell therapies for LBCL target CD19 alone, and dual targeting is intended to address relapse driven by antigen loss and tumor heterogeneity.

What clinical data support the designations?

The program is supported by long-term data from 48 patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with the agent in early-phase trials in China, which were presented at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in March 2026.² In this population, the overall response rate was 91.5%, the complete response rate was 85.1%, and the median progression-free survival was 60.1 months at a median follow-up of 53.9 months. The company reported a favorable safety profile.

The registrational phase 1b/2 ELEVATION trial (NCT05800977) evaluating prizlon-cel in patients with relapsed/refractory LBCL who have not received prior CAR T-cell therapy is ongoing in China.³

What are the next steps in US development?

The company plans to evaluate prizlon-cel in the phase 2 ABZT-121 trial (NCT07875413) in patients with relapsed/refractory LBCL previously treated with an FDA-approved, commercially available CAR T-cell therapy. They additionally intend to assess whether results from the study could support an accelerated approval pathway, depending on clinical results and discussions with the FDA.

AbelZeta is also planning a randomized study, ABZT-131, evaluating prizlon-cel in the second-line setting to assess its use earlier in treatment and its role relative to established CAR T-cell therapies.

“We look forward to working closely with the FDA as we advance both elements of this development strategy,” Liu said.¹

What is the regulatory history of prizlon-cel?

AbelZeta regained global development, regulatory, manufacturing, and commercialization rights to prizlon-cel in July 2026, and the FDA cleared the company’s IND application for the agent in August 2026.

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 13, 2026. https://tinyurl.com/yvkxf8xx
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 17, 2026. Accessed November 13, 2026. https://tinyurl.com/mwst8b3t
3. A study of C-CAR039 (prizloncabtagene autoleucel) in patients with relapsed/refractory large B-cell lymphoma (ELEVATION). ClinicalTrials.gov. Updated December 31, 2025. Accessed November 13, 2026. https://clinicaltrials.gov/study/NCT05800977