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A Multi-Center, phase 1/2 Trial of AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Abstract   Peer reviewed

A Multi-Center, phase 1/2 Trial of AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

Umar Farooq, Amitkumar Mehta, Erin A. Dean, Jennifer N. Saultz, Joseph Maly, Bassam Mattar, Adam J Olszewski, Ruthee Bayer, Gina Chu, Gilad Gordon, …
Transplantation and cellular therapy, Vol.32(2), pp.S372-S372
02/2026
DOI: 10.1016/j.jtct.2025.12.535

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Abstract

Introduction AlloNK is a highly scaled, non-genetically modified, allogeneic, off-the-shelf, cryopreserved NK cell therapy in development for the treatment of cancer and autoimmune diseases. AlloNK has been optimized for combination with monoclonal antibodies to enhance antibody-dependent cellular cytotoxicity and anti-tumor responses through selection of cord blood units for the CD16 high-affinity variant (158V/V) and KIR-B haplotype. Methods The objectives of this clinical trial (NCT04673617) were to assess safety and anti-tumor activity of AlloNK alone (monotherapy) and with rituximab in patients with CD20+ relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL). Patients received standard lymphodepletion (LD) and up to 4 cycles (4 weekly doses/cycle) of AlloNK at 1 × 109 or 4 × 109 cells/dose in an outpatient setting. Efficacy was evaluated using Lugano 2014 response criteria. Results As of September 4, 2025, 45 patients received AlloNK (16 across 3 monotherapy cohorts and 29 with rituximab across 4 combination cohorts). Most patients were White (82%), male (62%), with median age of 68 years, had aggressive NHL subtypes (84%), and had received a median of 4 prior lines of systemic therapy. The most common treatment-emergent adverse events (TEAEs) were hematologic in nature, as expected with the LD regimen. Infusion related-reactions (IRRs) and febrile neutropenia (7% each) were the only treatment related SAEs reported in more than 1 patient. CRS events were reported in 4 patients (9%; 3 Grade 1 cases, 1 Grade 2 case) and were attributed to IRRs (as they occurred within 24 hours of cell infusion, resolved without specialized treatment, and no cytokine elevations were noted). T cell therapy-associated toxicities such as ICANS and GvHD were not observed. There were no deaths related to AlloNK, and no patients discontinued the study from TEAEs related to AlloNK. Peripheral B-cell depletion was observed by day 15 and remained depleted over the first treatment cycle in all combination patients with detectable B cells at baseline. AlloNK was detectable in blood up to a week post-first dose but did not persist long-term. No new AlloNK-specific, anti-HLA antibodies were observed. The objective response rate was 37.5% and 55.2% in the monotherapy and combination treatment groups, respectively. In the 14 patients who were naïve to prior CAR-T therapies, 64.3% had complete responses and the Kaplan-Meier estimate of median duration of response was not reached but was at least 22.7 months. Conclusions The combination of AlloNK and rituximab was well-tolerated with promising efficacy seen in a heavily pretreated R/R NHL patient population, including older patients. No toxicities associated with T cell therapies (e.g., high rates of CRS and ICANS) were observed. These findings support the safe administration of AlloNK with rituximab in outpatient settings for oncology and autoimmune indications.

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