Non Hodgkin Lymphoma Clinical Trial

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

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)

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Full Description

This is a dose-finding study of NKX019 and will be conducted in 2 parts:

Part 1: dose finding utilizing a "3+3" enrollment schema and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts (as applicable) Part 2: dose expansion to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumor response in expansion cohorts of patients with large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT05020678

Recruitment Status:

Recruiting

Sponsor:

Nkarta Inc.

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There are 7 Locations for this study

See Locations Near You

Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Michael Tees, MD
Contact
720-754-4800
Savannah Harris
Contact
+1-720-754-8063
[email protected]
Michael Tees, MD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Brian Hill, MD PhD
Contact
216-445-9451
[email protected]
Brian Hill, MD PhD
Principal Investigator
Institute of Haematology, Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia More Info
Christian Bryant, MBSS PhD
Contact
+61 2 9515 8031
[email protected]
Christain Bryant, MBSS PhD
Principal Investigator
St. Vincent's Hospital
Sydney New South Wales, 2010, Australia More Info
Louise Christophersen
Contact
+61 2 9355 5702
[email protected]
Nada Hamad, MBSS BSc
Principal Investigator
Royal Brisbane and Woman's Hospital
Brisbane Queensland, 4029, Australia More Info
Glen W Kennedy, MBBS FRACP
Contact
+61 07 3646 7962
[email protected]
Glen Kennedy, MBSS FRACP
Principal Investigator
Peter MacCallum Cancer Center
Melbourne Victoria, 3000, Australia More Info
Parkville Cancer Clinical Trials Unit
Contact
+61 3 8559 7456
[email protected]
Michael Dickinson, MBSS DMedSci
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT05020678

Recruitment Status:

Recruiting

Sponsor:


Nkarta Inc.

How clear is this clinincal trial information?

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