NCT05020678Active, not recruitingPhase 1
NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 20 Aug 2021
- Start date
- 20 Aug 2021
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Nkarta, Inc.
- NCT number
- NCT05020678
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 20 Aug 2021 to the primary completion date, 31 Mar 2025
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with WM who underwent plasmapheresis \<35 days prior to the first dose of NKX019
- Subjects with any prior cellular therapy except subjects enrolling in selected cohorts who must have received prior 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
Other illness
- Disease related:
- Subjects with NHL with any evidence of active CNS malignancy
- Subjects with B-ALL who have extramedullary disease (EMD)
Other
- Burkitt Lymphoma, primary central nervous system (CNS) lymphoma, Richter's transformation to Hodgkin lymphoma
- Pregnant or lactating female
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brisbane and Woman's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Institute of Haematology, Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| The Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.