Off-the-Shelf cell therapy takes on tough blood cancers
NCT ID NCT05020678
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental therapy called NKX019 for people with certain blood cancers (like lymphoma and leukemia) that have come back or not responded to standard treatments. NKX019 uses donor immune cells (natural killer cells) that are engineered to find and attack cancer cells. The study will enroll about 150 participants to check safety and find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NKX019 (a type of immune cell called a natural killer cell, engineered to target cancer cells)
- What this could lead to
- If it works, this could provide a new, off-the-shelf cell therapy option for people with hard-to-treat B-cell cancers, potentially with fewer side effects than current treatments.
- What could go wrong
- This is an early Phase 1 trial, so the main goal is safety, not yet proof of effectiveness. The therapy may not work for everyone, and there could be unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Dec 2038
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Institute of Haematology, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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Peter MacCallum Cancer Center
Melbourne, Victoria, 3000, Australia
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Royal Brisbane and Woman's Hospital
Brisbane, Queensland, 4029, Australia
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St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
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The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental therapy SNC116 put to the test against Hard-to-Treat leukemia
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Two-Drug combo aims to push CLL into deep remission