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

Authors

• Justin Darrah
• Indumathy Varadarajan
• Amitkumar Mehta
• Jennifer Saultz
• Matthew McKinney
• Monalisa Ghosh
• Usama Gergis, Thomas Jefferson UniversityFollow
• Andrew Krueger
• Kevin Galinsky
• Girish Bende
• Ajeetha Ramachandran
• Varsha Sundaresan
• Siddha Kasar
• Bradley Hupf
• Sharon Chen
• Leopold Sellner
• Reem Karmali

Document Type

Article

Publication Date

10-8-2026

Comments

This article is the author’s final published version in Blood Cancer Discovery, 2026.

The published version is available at https://doi.org/10.1158/2643-3230.BCD-25-0323-A. Copyright © 2026 The Authors.

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.

Recommended Citation

Darrah, Justin; Varadarajan, Indumathy; Mehta, Amitkumar; Saultz, Jennifer; McKinney, Matthew; Ghosh, Monalisa; Gergis, Usama; Krueger, Andrew; Galinsky, Kevin; Bende, Girish; Ramachandran, Ajeetha; Sundaresan, Varsha; Kasar, Siddha; Hupf, Bradley; Chen, Sharon; Sellner, Leopold; and Karmali, Reem, "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" (2026). Department of Medical Oncology Faculty Papers. Paper 351.
https://jdc.jefferson.edu/medoncfp/351

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.

PubMed ID

41995697

Language

English