Prizlon-Cel Nets FDA RMAT and Fast Track Designations in R/R LBCL

The FDA has granted RMAT and fast track designation to prizloncabtagene autoleucel (prizlon-cel; A-CAR039), an investigational autologous CAR T-cell therapy directed against both CD19 and CD20, for patients with relapsed/refractory large B-cell lymphoma (LBCL).¹

Notably, the company did not disclose the specific data behind the designations. Althought, prizlon-cel was previously studied in a pooled analysis of 4 phase 1 trials (NCT04317885, NCT04655677, NCT04696432, and NCT04693676) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, published in Blood.² LBCL accounted for 44 of the 48 patients who were infused. In the overall population, the objective response rate (ORR) was 91.5% and the complete response (CR) rate was 85.1%. Among patients with LBCL, the ORR was 90.7% and the CR rate was 86.0%. The estimated 2-year duration of response (DOR), progression-free survival (PFS), and overall survival (OS) rates were 66.0%, 62.6%, and 76.5%, respectively.

Moreover, cytokine release syndrome developed in 93.8% of patients, and 1 of these cases was grade 3. Immune effector cell–associated neurotoxicity syndrome developed in 6.3% of patients, and none of these cases was grade 3 or higher.

“These dual FDA designations are important milestones for Prizlon-cel,” said Tony Liu, chief executive officer of AbelZeta in a news release.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, while we are also preparing to evaluate prizlon-cel earlier in the treatment course through a randomized second-line program.”

How was the ABZT-121 trial designed?

AbelZeta plans to evaluate prizlon-cel in the phase 2 ABZT-121 trial (NCT07875413), a single-arm, open-label study at multiple centers with an estimated enrollment of 55 patients.¹^,³

Eligible patients for the trial are at least 18 years of age with with relapsed/refractory LBCL subtypes defined in the 2022 WHO classification such as, diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, DLBCL/high-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements, HGBL not otherwise specified, or follicular large B-cell lymphoma.³

Patients also need to have measurable disease per Lugano 2014 Classification and received at least 2 earlier lines of standard therapy. One of these must be a commercially available, FDA-approved CAR T-cell product given at least 3 months before enrollment.

Patients will be excluded if they have had received a prior an allogeneic hematopoietic stem cell transplant, an autologous transplant within 12 weeks before leukapheresis, or any previous investigational CAR T-cell therapy.

After leukapheresis, patients receive lymphodepletion with fludarabine and cyclophosphamide, followed by a single intravenous infusion of prizlon-cel.

The 2 primary end points, each assessed through month 24, are ORR, comprising CR and partial response by Lugano 2014 criteria, as well as the incidence and severity of adverse effects. Secondary end points for the trial include, DOR, CR rate, best overall response, PFS, and OS.

Follow-up lasts 24 months, and long-term safety monitoring continues for as long as 15 years. The trial has not begun recruiting. Its estimated start date is May 2027, and its estimated primary completion date is June 2029.

What are the next steps for prizlon-cel in LBCL?

AbelZeta plans to determine whether findings from ABZT-121 could support accelerated approval in the post–CAR T-cell therapy setting, depending on the data.¹ The company is also developing the randomized ABZT-131 study of prizlon-cel in second-line relapsed/refractory LBCL. This trial will test the agent at an earlier point in treatment and help clarify where it fits alongside approved CAR T-cell products.

References

1. AbelZeta receives FDA RMAT and fast track designations for prizlon-cel in relapsed or refractory large B-cell lymphoma. News release. AbelZeta Inc. November 10, 2026. Accessed November 10, 2026. https://www.prnewswire.com/news-releases/abelzeta-receives-fda-rmat-and-fast-track-designations-for-prizlon-cel-in-relapsed-or-refractory-large-b-cell-lymphoma-302934695.html
2. Yu W, Li P, Zhou L, et al. A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2025;145(14):1526-1535. doi:10.1182/blood.2024026401
3. Prizloncabtagene autoleucel (prizlon-cel) for the treatment of relapsed or refractory large B-cell lymphoma post FDA approved CAR T-cell therapy (ABZT-121). ClinicalTrials.gov. Updated October 15, 2026. Accessed November 10, 2026. https://clinicaltrials.gov/study/NCT07875413