NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers

Running, not enrolling · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Aggressive Lymphoma, Large-cell Lymphoma

In brief

This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL)

Key facts

Study ID

NCT05020678

Run by

Nkarta, Inc.

People needed

150

Starts

2021-08-20

Expected to finish

2038-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General:
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Disease Related:
• Have a histologically or cytologically confirmed diagnosis of r/r B cell NHL or CLL or B-ALL as defined by WHO 2016 classification
• Subjects who received prior CD19/CD20-directed therapy must have disease that remains CD19+ and/or CD20+ respectively
• Have measurable disease
• Have received ≥2 lines of therapy except subjects with MCL, CAR T Naïve cohorts and WM, who must have received at least 1 prior line of therapy
• Have received a combination of an anti CD20 monoclonal antibody and cytotoxic chemotherapy for subjects with NHL
• Received:
• BTKi for subjects with MCL, CLL/SLL, WM, and other indications where a BTKi is approved
• Venetoclax for subjects with CLL/SLL
• Tyrosine kinase inhibitor for subjects with Philadelphia chromosome (Ph+) B-ALL
• Not responded or relapsed within 12 months of completion of their prior line of therapy, with the exception of a newly diagnosed Richter's transformation of CLL/SLL or other transformation of an indolent lymphoma, including from WM
• Subjects must not have evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment.
• Adequate organ function
• White blood cell count of ≤20 × 109/L
• Platelet count ≥30,000/uL

You may not qualify if…

• Disease related:
• Burkitt Lymphoma, primary central nervous system (CNS) lymphoma, Richter's transformation to Hodgkin lymphoma
• Subjects with WM who underwent plasmapheresis <35 days prior to the first dose of NKX019
• Subjects with NHL with any evidence of active CNS malignancy
• Subjects with B-ALL who have extramedullary disease (EMD)
• Subjects with any prior cellular therapy except subjects enrolling in selected cohorts who must have received prior CAR T therapy, recent HCT, or complications from HCT
• Recent use of any cancer-directed therapy within protocol specified window prior to the first dose of NKX019
• Residual toxicities ≥Grade 2 due to prior therapy
• Other comorbid conditions and concomitant medications prohibited as per study protocol
• Pregnant or lactating female

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Institute of Haematology, Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• St. Vincent's Hospital — Sydney, New South Wales, Australia
• Royal Brisbane and Woman's Hospital — Brisbane, Queensland, Australia
• Peter MacCallum Cancer Center — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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