NKX019

P1, N=21, Recruiting, Nkarta, Inc.

P1, N=6, Recruiting, Columbia University

P1, N=150, Recruiting, Nkarta Inc. | Trial primary completion date: Dec 2023 --> Aug 2024

Following 3 days of lymphodepletion (LD) with fludarabine at 30 mg/m 2 /d and cyclophosphamide at 300 mg/m 2 /d, patients received NKX019 at 3 dose levels (3 × 10 8 , 1 × 10 9 , or 1.5 × 10 9 CAR + NK cells/dose x 3 doses on days 0, 7, and 14 of a 28-day cycle). These preliminary data suggest that NKX019 has a manageable safety profile with monotherapy activity across multiple histologies of B-cell NHL. Enrollment into the expansion cohorts is currently ongoing and will evaluate the RP2D in multiple cohorts: (1) CAR-T naïve LBCL, (2) CAR-T exposed LBCL, and (3) in combination with rituximab to evaluate for enhanced anti-tumor activity via ADCC. NK cell, Cellular therapy, Non-Hodgkin's lymphoma

P1, N=150, Recruiting, Nkarta Inc. | N=60 --> 150 | Trial completion date: Jul 2038 --> Dec 2038 | Trial primary completion date: Jul 2023 --> Dec 2023

CD20-targeted mAbs such as rituximab (RTX) and obinutuzumab (OBI), can mediate antibody-dependent cellular cytotoxicity (ADCC), a key effector mechanism of NK cells. Conclusions This study demonstrates increased activity and persistence of NKX019 when used in combination with approved CD20-targeted mAbs, RTX and OBI, against B cell malignancies. A first-in -human Phase I clinical trial of NKX019 in combination with RTX is planned.

NKX019 will be administered on Days 0, 7, and 14 of a 28-day cycle following standard fludarabine/cyclophosphamide lymphodepletion (Table). Subjects will be assessed for efficacy using disease-specific criteria: Lugano classification with LYRIC refinement for pseudo-progression (NHL), 2018 International Workshop (IW) criteria (CLL), 6th IW criteria (Waldenström macroglobulinemia [WM]), and National Comprehensive Cancer Version 1.2020 (B-ALL) (Cheson 2006, Cheson 2014, Hallek 2018, Owen 2013, Brown 2020). Enrollment across multiple sites in the US and Australia is expected to start in the second half of 2021.

P1, N=60, Recruiting, Nkarta Inc.

A first-in-human trial of NKX019 in B cell malignancies is planned for 2021. Ethics Approval The animal procedures described in this abstract were conducted in accordance with Explora BioLabs Animal Care and Use Protocol approved by Explora BioLabs Institutional Animal Care and Use Committee.

A first-in-human trial of NKX019 in B cell malignancies is planned for 2021. Ethics Approval The animal procedures described in this abstract were conducted in accordance with Explora BioLabs Animal Care and Use Protocol approved by Explora BioLabs Institutional Animal Care and Use Committee.