Brief 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 cellsthe basic structural and functional unit of all living things targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphomacancers of the lymphatic system (NHL), chronica long-lasting disease that changes slowly over time lymphocytic leukemia (CLL) or B cell acutenew, recent, comes with an urgent or significant sense, is sudden, sharp lymphoblastic leukemia (B-ALL).
Intervention / Treatment
- Biological: NKX019
Inclusion Criteria
General:
Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status ≤1
• Disease Related:
- Have a histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses and cytotoxic chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells 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 bloodthe red bodily fluid that transports oxygen and other nutrients around the body cell count of ≤20 × 109/L
- Platelet count ≥30,000/uL