CAR T-Cell Therapy Earns FDA IND Clearance in Large B-Cell Lymphoma

The FDA has cleared an investigational new drug (IND) application for prizloncabtagene autoleucel (C-CAR039; prizlon-cel), an 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 AbelZeta Pharma, Inc.¹

What is prizlon-cel and how does it work?

Prizlon-cel is a second-generation, 4-1BB–costimulated CAR T-cell therapy engineered to target both CD19 and CD20, 2 antigens commonly expressed on the surface of malignant B cells. By binding both targets simultaneously, the bispecific design is intended to reduce the risk of antigen-negative relapse, a mechanism of resistance that can limit the durability of single-target, CD19-directed CAR T-cell therapies in B-cell non-Hodgkin lymphoma (B-NHL).

Who will be eligible for treatment with prizlon-cel?

The developers are working with the FDA to finalize protocols for clinical development of prizlon-cel in 2 patient populations: those with third-line or later LBCL who have previously received CAR T-cell therapies, and those with second-line LBCL who are CAR T-cell therapy naive. The IND clearance positions prizlon-cel to address patients who have progressed after commercially approved CD19-directed CAR T-cell products, a population the company has described as having substantial unmet medical need.

What clinical data support prizlon-cel in relapsed/refractory B-NHL?

The IND clearance is supported by long-term data presented at the European Society for Blood and Marrow Transplantation (EBMT) meeting in March 2026, drawn from AbelZeta’s early clinical trials of prizlon-cel in China, including a phase 1, single-center, open-label study in patients with R/R B-NHL (NCT05149391).²

Those selected for enrollment were 18 to 70 years of age, with an expected survival of at least 12 weeks, and an ECOG performance status of 0 to 2. Moreover, those eligible for enrollment had no contraindications of apheresis and at least 1 measurable lesion according to Lugano 2014 criteria.

Among 48 patients with relapsed/refractory B-NHL, prizlon-cel produced an overall response rate (ORR) of 91.5% and a complete response (CR) rate of 85.1%. At a median follow-up of 53.9 months, the median progression-free survival (PFS) was 60.1 months, and investigators reported a favorable safety profile.

What is AbelZeta’s regulatory and licensing history with prizlon-cel?

In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing, and other collaboration rights relating to prizlon-cel following a prior partnership arrangement. “We are pleased to welcome [prizlon-cel] back to our hematology malignancy portfolio,” stated Tony (Bizuo) Liu, chairman and chief executive officer of AbelZeta, in the press release.¹ “Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of [prizlon-cel] in [patients with relapsed/refractory] LBCL. 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 [prizlon-cel] represents a solution.”

What’s next for prizlon-cel in large B-cell lymphoma?

A registrational phase 2 trial of prizlon-cel in CAR T-cell therapy–naive patients with relapsed/refractory LBCL remains ongoing in China.¹ The developer plan to explore the therapy in earlier lines of LBCL treatment as it advances prizlon-cel’s global development program. The company is building a pipeline of CAR T-cell therapies spanning hematologic malignancies, inflammatory and immunologic diseases, and solid tumors in China and the US.

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. August 16, 2026. Accessed August 17, 2026. https://tinyurl.com/5afvmu25
2. A study of C-CAR039 in subjects with relapsed and/or refractory B cell non-Hodgkin’s lymphoma. ClinicalTrials.gov. Updated January 30, 2026. Accessed August 17, 2026. https://tinyurl.com/ytakvknv