The chimeric antigen receptor T-cell therapy zamtocabtagene autoleucel (zamto-cel) showed encouraging activity and a favorable safety profile in patients with relapsed or refractory diffuse large B-cell lymphoma after at least two prior lines of therapy, according to an interim analysis presented at the tandem meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research.
The analysis comes from the US-based DALY II trial, a multicenter, open-label, single-arm phase 2 study. The results, presented by Nirav Shah, MD, an associate professor of medicine at the Medical College of Wisconsin, highlighted the potential of this dual CD20-CD19 CAR-T therapy, which is designed to shorten manufacturing time and get treatment to patients faster.
“Unlike currently registered CAR-T cell products, zamto-cel is administered as a fresh product with a short vein-to-vein time and a high manufacturing success rate,” the investigators wrote.
The therapy is manufactured by Miltenyi Biotec using its CliniMACS Prodigy(R) platform, a closed, automated system with an approximately 14-day vein-to-vein time.
“We believe that making CAR-T treatments more globally accessible—and advancing medicine like this—is one of our major goals at Miltenyi,” said Toon Overstijns, CEO of Miltenyi Biomedicine, in an interview with SOHO Insider at the 66th American Society of Hematology Annual Meeting and Exposition.
Results
The investigators reported that as of March 29, 2024, 69 patients had received zamto-cel. Among 59 evaluable patients (median age, 63 years; 66% male), the overall response rate was 72.9%, including a complete response rate of 49.2%. At 6 and 12 months, progression-free survival was 55% and 42%, respectively, and overall survival at 12 months was 72%. The median duration of response was 11.4 months.
All 69 treated patients were included in the safety analysis. Cytokine release syndrome occurred in 46% of patients and was limited to grade 1–2 events. Neurotoxicity was reported in 17%, with most cases grade 1–2 and 4% grade 3. One case of IEC-HS was reported and resolved within two days. There were no reported patient deaths.
Only one patient lost both target antigens at relapse, suggesting target expression was largely maintained, the investigators wrote.
“Only one patient experienced loss of both antigens compared to pretreatment status, demonstrating maintenance of target antigen expression at relapse,” they wrote.
This study was presented as oral abstract 43 in the “Myeloma and Lymphoma” session during the 2026 Tandem meetings in Honolulu.
