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ACTIVE NOT RECRUITING
NCT05020678
PHASE1

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

Sponsor: Nkarta, Inc.

View on ClinicalTrials.gov

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)

Official title: A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-08-20

Completion Date

2038-12

Last Updated

2024-12-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

Locations (6)

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