Breakthrough Study Confirms Safety and Efficacy of CD19/CD20 CAR-T Therapy for r/r B-NHL
A new study published in Bloodhighlights the successful development of prizloncabtagene autoleucel (prizlon-cel), an innovative CD19/CD20-targeting CAR-T cell therapy, for treating relapsed/refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL). The trial, a phase 1, multicenter, open-label study conducted in China, offers promising data on the safety and efficacy of this dual-targeted approach.
Led by a team of prominent researchers from institutions including Zhejiang University’s First Affiliated Hospital and Tongji University, the study enrolled 48 patients with r/r B-NHL, predominantly large B-Cell Lymphoma (LBCL). Patients had previously undergone a median of three lines of therapy. Participants received a single infusion of prizlon-cel after lymphodepleting chemotherapy, with doses ranging across three levels (DL1, DL2, and DL3).
Key Findings:
- Safety Profile: No dose-limiting toxicities (DLT) were observed, and the therapy showed manageable side effects. Cytokine release syndrome (CRS) occurred in 93.8% of patients, mostly grade 1–2, with only one grade 3 case. Immune effector cell-associated neurotoxicity syndrome (ICANS) was rare and mild, with no grade 3 or higher events.
- Efficacy: An overall response rate (ORR) of 91.5% was achieved, with a complete response (CR) rate of 85.1%. Among LBCL patients, the ORR and CR rates were 90.7% and 86.0%, respectively. Remarkably, 48.9% of patients maintained CR at the last follow-up, with some responses exceeding three years.
- Survival Outcomes: Kaplan-Meier estimates revealed 2-year durations of response (DOR), progression-free survival (PFS), and overall survival (OS) rates of 66.0%, 62.6%, and 76.5%, respectively. In CR patients, these rates were even higher.
Prizlon-cel demonstrated robust expansion and long-term persistence, with a median B-cell recovery time of 185 days. Its dual-targeted design addresses antigen escape, a common resistance mechanism in CAR-T therapies.