NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers (NCT05020678)
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (11 items).
Location: Colorado Blood Cancer Institute — Denver, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Colorado Blood Cancer Institute — Denver, Colorado
- The Cleveland Clinic Foundation — Cleveland, Ohio
- Institute of Haematology, Royal Prince Alfred Hospital — Camperdown, New South Wales
- St. Vincent's Hospital — Sydney, New South Wales
- Royal Brisbane and Woman's Hospital — Brisbane, Queensland
- Peter MacCallum Cancer Center — Melbourne, Victoria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lymphoma, Non-Hodgkin
- A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008) — Denver, Colorado
- Family Study of Lymphoproliferative Disorders — Rochester, Minnesota
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) — Edmonton, Alberta
- A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) — Duarte, California
- A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) — Santa Monica, California
Explore by condition: All Lymphoma, Non-Hodgkin clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.