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

  • STATUS
    Recruiting
  • End date
    Jul 24, 2038
  • participants needed
    60
  • sponsor
    Nkarta Inc.
Updated on 24 March 2022
platelet count
tyrosine
lymphoma
monoclonal antibodies
measurable disease
leukemia
lymphocytic leukemia
venetoclax
white blood cells
monoclonal antibody therapy
chemotherapy regimen
monoclonal protein
immunoglobulin
indolent lymphoma
refractory non-hodgkin's lymphoma
b-cell small lymphocytic lymphoma

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)

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. 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.

Details
Condition 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
Treatment NKX019
Clinical Study IdentifierNCT05020678
SponsorNkarta Inc.
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

General
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-directed therapy must have disease that remains CD19+
Have measurable disease
Have received ≥2 lines of therapy except subjects with MCL 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
Adequate organ function
therapy, with the exception of a newly diagnosed Richter's transformation of
CLL/SLL or other transformation of an indolent lymphoma, including from WM
White blood cell count of ≤20 × 109/L
Platelet count ≥30,000/uL

Exclusion Criteria

Burkitt Lymphoma, primary CNS lymphoma, Richter's transformation to Hodgkin lymphoma
• Disease related
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 LBCL expansion cohort who must have received prior CD19 directed 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
Other comorbid conditions and concomitant medications prohibited as per study protocol
Pregnant or lactating female
Residual toxicities ≥Grade 2 due to prior therapy
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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