During the European Hematology Association (EHA) Congress, which was held June 12 – 15, 2025, in Milan, Italy, scientists from AbelZeta Pharma, formerly known as Cellular Biomedicine Group, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel).
C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients.
The study, conducted in greater China, evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies.
Key Findings:
- The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients
- Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively
- With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached
- KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively
- KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively
Safety Highlights:
- CRS of any grade: 93.8% | Grade ≥3: 2.1%
- ICANS of any grade: 6.3% | No severe cases (Grade ≥3) reported
- No new safety signals were observed with longer follow-up
Excellent Safety profile
C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing.
“The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta.
“These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer,” Liu added.
“The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies – such as CD19 antigen escape – C-CAR039 enables deeper tissue penetration and more complete B-cell depletion,” explained Yihong Yao, MD, Ph.D., Chief Scientific Officer of AbelZeta.
The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies,” Yao concluded.
__
Note:* In an oral presentation 30-month Phase 1 clinical trial results for both C-CAR039 for the reatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL), and C-CAR066, for the treatment of patients with r/r large B-cell lymphoma (LBCL) who failed prior CD19 CAR-T therapy were at the 65th American Society of Hematology (ASH) Annual Meeting held in Dcember 2023/ [Abstract | C-CAR039][Abstract | C-CAR066], as well as at EHA 2024, through poster presentation [Abstract | P1475]. The data with 30 months follow-up was published in Blood 2025 Apr 3;145(14):1526-1535.[Article ] [3]
Clinical trials
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects – ClinicalTrials.gov ID NCT04317885
A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin’s Lymphoma – ClinicalTrials.gov ID NCT04655677
A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin’s Lymphoma – ClinicalTrials.gov ID NCT04696432
A Study of C-CAR039 Treatment in Subjects With r/r NHL Subjects Non-Hodgkin’s Lymphoma – ClinicalTrials.gov ID NCT04693676
Reference
[1] Li P, Yu WJ, Zhou L, Yang M, Ye S*, Zhu J, Huang J, Zhang Y, Li L, Zhao J, Zhu K, Li J, Zheng C, Lan L, Wan H, Yao Y, Zhang H, Zhou D, MD6*, Jie J, Liang A. 1025 C-CAR039, a Novel Anti-CD20/CD19 Bi-Specific CAR T-Cell Therapy Shows Deep and Durable Clinical Benefits in Patients with Relapsed or Refractory (r/r) B-Cell Non-Hodgkin Lymphoma (B-NHL) in Long Term Follow up. Oral Presentation during the 2023 ASH. Presented on Monday, December 11, 2023: 5:30 PM
[2] Li P, Liu W, Ye S, Zhou L, Zhu J, Huang J, Li J, Zhu S, Zheng C, Zhu K, Yao X, Wan H, Yao Y, Liang A, Zou D. 2115 Two-Year Follow-up Results of C-CAR066, a Novel Anti-CD20 Chimeric Antigen Receptor Cell Therapy (CAR-T) in Relapsed or Refractory (r/r) Large B-Cell Lymphoma (LBCL) Patients after Failure of CD19 CAR-T Therapy. Poster Presentation during the 2023 ASH. Presented on Saturday, December 9, 2023, 5:30 PM-7:30 PM
[3] Yu W, Li P, Zhou L, Yang M, Ye S, Zhu D, Huang J, Yao X, Zhang Y, Li L, Zhao J, Zhu K, Li J, Zheng C, Lan L, Wan H, Yao Y, Zhang H, Zhou D, Jin J, Liang A. A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2025 Apr 3;145(14):1526-1535. doi: 10.1182/blood.2024026401. PMID: 39813680.
Featured image: Galleria Vittorio Emanuel II, Milan, Italy, by Alessandro Rossi on Unsplash. Photo courtesy: © 2021 – 2025 Unsplash. Used with permission.
DOI
