A Phase 2, Open-Label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma.
Publication/Presentation Date
4-17-2026
Abstract
In relapsed/refractory large B-cell lymphoma (LBCL), chimeric antigen receptor (CAR)-natural killer (NK) cell therapies offer potential advantages over CAR-T-cell therapies, including off-the-shelf availability and scalable manufacturing. We performed a phase 2 study of single-dose TAK-007, a cryopreserved, cord blood-derived, off-the-shelf CD19 CAR-NK cell therapy, in 26 heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). Adverse events were manageable, with limited grade 1-2 cytokine release syndrome (11.5%). Overall response rate with TAK-007 800 x106 CD19 CAR+ viable NK cells (n=14) was 60.9% (95% CI: 38.5-80.3). Median progression-free survival was 2.0 months (95% CI: 0.99-3.58) in LBCL (n=10) and 5.6 months (95% CI: 1.05-8.57) in indolent NHL (n=7) expansion cohorts. Deep molecular responses, including ctDNA-negative responses, were achieved. Not all TAK-007 products elicited clinical responses; single cell RNA-sequencing showed NK proliferating and NK-CD56dim cell enrichment in TAK-007 products eliciting/not eliciting responses, respectively, which could inform product selection.
ISSN
2643-3249
Published In/Presented At
Darrah, J. M., Varadarajan, I., Mehta, A., Saultz, J. N., McKinney, M. S., Ghosh, M., Gergis, U., Krueger, A., Galinsky, K. J., Bende, G., Ramachandran, A., Sundaresan, V., Kasar, S., Hupf, B., Chen, S., Sellner, L., & Karmali, R. (2026). A Phase 2, Open-Label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. Blood cancer discovery, 10.1158/2643-3230.BCD-25-0323-A. Advance online publication. https://doi.org/10.1158/2643-3230.BCD-25-0323-A
Disciplines
Medicine and Health Sciences
PubMedID
41995697
Department(s)
Hematology-Medical Oncology Division
Document Type
Article