Nkarta's Allogeneic CAR T Shows Clinical Responses in Non-Hodgkin Lymphoma

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Patients with non-Hodgkin lymphoma in Nkarta's phase 1 study had a 75% complete response rate.

Nkarta’s allogeneic chimeric antigen receptor (CAR) T-cell therapy NKX019 has shown promising responses as a monotherapy in patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL) in updated data from a phase 1 study (NCT05020678).

“NKX019 continues to demonstrate impressive single-agent activity, preliminary durability and an encouraging safety profile as an off-the-shelf, on-demand cell therapy for heavily pre-treated patients with NHL,” Paul J. Hastings, president and chief executive officer,Nkarta, said in a statement. “Based on this initial success, we recently opened dose expansion cohorts to explore combination and single-agent regimens in patients with LBCL, an especially aggressive form of lymphoma, and to address the large unmet need in patients who have received prior autologous CAR T therapy. We remain committed to improved access for patients through the integration of cell therapy into the broader outpatient setting.”

Updated data were from 19 patients enrolled and dosed as of November 28, 2022, at clinical trial sites in Australia (n = 13) and the US (n = 6). Participants hadNHL (n = 14) and 7had aggressive large B-cell lymphoma. Participants had a median of 4 prior lines of therapy (range, 2-10). Most of the 10 patients (n = 8) achieved an objective response (OR rate, 80%) in the 2 highest dose cohorts (3 doses of 1 billion and 3 doses of 1.5 billion cells), with 7 patients achieving a complete response (CR; 70%). Five of 6 patients with NHL in the 3 x 1 billion cell dose cohort had an OR (83%) with 4 CRs (67%) and 3 of 4 patients receiving 3 x 1.5 billion cells had an OR (75%) and a CR (75%). Altogether, 10 of 14 patients with NHL had an OR (71%) and 8 had a CR (75%). Three patients with acute lymphocytic leukemia and 2 with chronic lymphocytic leukemiawere also treated but had no response.

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In terms of safety, NKX019 was well-tolerated with no immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease,serious cytokine release syndrome (CRS) cases, or dose-limiting toxicities observed. Adverse events (AEs) included fever (n = 5), infusion-related reactions (n = 2), CRS (n = 2) and the most common severe AE was myelosuppression.

The trial is also assessing NKX019 as a combination therapy with rituximab.Nkarta plans to provide more updated data from the NKX019 program, including data from the dose expansion cohorts, in 2023.

“Autologous CAR T cell therapy has undeniably changed the NHL treatment landscape, but the possibility of severe toxicity and the limited access of these therapies leave many potentially eligible patients without a cellular therapy option,” investigator Michael Dickinson, MD, Lead, Aggressive Lymphoma disease group, Clinical Hematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, added to the statement. “In the data so far, NKX019 has shown encouraging anti-tumor activity, including in patients with aggressive histologies, who are the patients who are most in need.”

REFERENCE
Nkarta announces updated clinical data on anti-CD19 allogeneic CAR-NK cell therapy NKX019 for patients with relapsed or refractory non-Hodgkin lymphoma. News release. Nkarta. December 6, 2022. https://finance.yahoo.com/news/nkarta-announces-updated-clinical-data-120200121.html
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