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)
∙ 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