NKX019

P1/2, N=96, Recruiting, Nkarta, Inc. | Phase classification: P1 --> P1/2 | N=48 --> 96

P1/2, N=144, Recruiting, Nkarta, Inc. | Phase classification: P1 --> P1/2 | N=72 --> 144

P1, N=48, Recruiting, Nkarta, Inc. | N=21 --> 48

P1, N=150, Active, not recruiting, Nkarta, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2024 --> Mar 2025

P1, N=90, Recruiting, Nkarta, Inc.

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.