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Clinical Trials in the USA / NCT05020678
Active, not recruiting Phase 1

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

NCT05020678 · tracked via the Priya Life Science USA tracker
Sponsor
Nkarta, Inc.
Phase
Phase 1
Started
2021-08-20
Last updated
2026-04-20

Condition(s) studied

Lymphoma, Non-HodgkinB-cell Acute Lymphoblastic LeukemiaLarge B-cell LymphomaMantle Cell LymphomaIndolent LymphomaWaldenstrom MacroglobulinemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaAggressive LymphomaLarge-cell Lymphoma

Investigational drug(s) / intervention(s)

NKX019

NKX019: NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10\^8 NK cells (6 × 10\^6/kg for patients \< 50 kg) administered as 3 weekly doses. Part 2 (dose expansion cohorts) will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX019 as determined in Part 1.

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: • 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

Primary outcome measure(s)

Trial sites (6)

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

More Nkarta, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05020678 on ClinicalTrials.gov ↗ ← All trials in the USA