Clinical trial · Interventional
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
NCT05020678CI-TRIAL-00108847active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Lymphoma | Aggressive Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Indolent Lymphoma | Indolent Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Large B-cell Lymphoma | — | UNRESOLVED | — |
| Large-cell Lymphoma | — | UNRESOLVED | — |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKX019 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NKX019 - CAR NK cell therapy
- description
- 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.
- interventionNames
- Biological: NKX019
Primary outcomes (3)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 30 days after last dose of NKX019
- description
- Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease.
- measure
- Proportion of subjects experiencing dose-limiting toxicities of NKX019
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: • Disease related: * Burkitt Lymphoma, primary central nervous system (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 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 * Pregnant or lactating female
References
Publications (0)
Data not yet available
No reference posted for this study.