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

Who is this study for? Patients with B-cell malignancies
What treatments are being studied? NKX019
Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
United States
Colorado
Colorado Blood Cancer Institute
Denver
Ohio
The Cleveland Clinic Foundation
Cleveland
Other Locations
Australia
Royal Brisbane and Woman's Hospital
Brisbane
Institute of Haematology, Royal Prince Alfred Hospital
Camperdown
Peter MacCallum Cancer Center
Melbourne
St. Vincent's Hospital
Sydney
Time Frame
Start Date: 2021-08-20
Completion Date: 2038-12
Participants
Target number of participants: 150
Treatments
Experimental: NKX019 - CAR NK cell therapy
All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by 3 weekly doses of NKX019 on Day 0, 7, and 14 of a 28-day cycle. Combination cohorts (if opened) will additionally receive rituximab with each cycle.
Authors
Sponsors
Leads: Nkarta, Inc.

This content was sourced from clinicaltrials.gov