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

  • Interventional
  • Recruiting
  • NCT05020678
Eligibility Details Visit Clinicaltrials.gov

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

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)

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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 therapy, with the exception of a newly diagnosed Richter's transformation of CLL/SLL or other transformation of an indolent lymphoma, including from WM

         - Adequate organ function

         - White blood cell count of ≤20 × 109/L

         - Platelet count ≥30,000/uL

        Exclusion Criteria:

        • Disease related:

         - Burkitt Lymphoma, primary 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 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

         - Residual toxicities ≥Grade 2 due to prior therapy

         - Other comorbid conditions and concomitant medications prohibited as per study protocol

         - Pregnant or lactating female

At a Glance

National Government IDNCT05020678

IRB#IRB21-0774

Lead SponsorNkarta Inc.

Lead PhysicianHongtao Liu

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting