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Experimental drug boosts Cancer-Killing cells in lymphoma trial

NCT ID NCT05359211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This early-phase trial tests whether adding an experimental drug called NKTR-255 to standard CAR-T cell therapy can improve outcomes for people with large B-cell lymphoma that has returned or not responded to treatment. The study involves 27 adults and focuses on safety and how well the combination works. NKTR-255 is designed to strengthen the immune system's cancer-fighting cells, while the CAR-T cells are engineered to recognize and destroy lymphoma cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NKTR-255 (an immune-boosting drug) and lisocabtagene maraleucel (CAR-T cells that target cancer)
What this could lead to
If it works, this combination could improve the ability of CAR-T therapy to fight hard-to-treat lymphoma, potentially leading to better remission rates.
What could go wrong
This is a very early (Phase 1) trial with only 27 people, so results may not apply broadly. There is also a risk of serious side effects from the immune system overreacting.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female \>= 18 years of age at the time of consent * Patients with LBCL (including diffuse large B-cell lymphoma \[DLBCL\] not otherwise specified \[including DLBCL arising from indolent lymphoma\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with a Food and Drug Administration (FDA)-approved indication for treatment with liso-cel * Fludeoxyglucose F-18 (FDG)-avid disease on positron emission tomography (PET) imaging or pathology evidence of active disease * Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology * Karnofsky performance status \>= 60% * Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3 in the absence of bone marrow involvement by lymphoma * Platelets \>= 50,000 cells/mm\^3 in the absence of bone marrow involvement by lymphoma * Hemoglobin \>= 8 g/dL in the absence of bone marrow involvement by lymphoma * Calculated creatinine clearance (Cockcroft/Gault) \> 30 mL/min/1.73 m\^2 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (or \< 5 x ULN for subjects with lymphomatous infiltration of the liver) * Total bilirubin =\< 2 (or \< 3.0 for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver) * Common Terminology Criteria for Adverse Events (CTCAE) Grade =\< 1 dyspnea * Saturation of oxygen (Sa02) \>= 92% on room air * Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing and must have a forced expiratory volume in 1 second (FEV1) of \>= 50% of predicted value * Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing and must have a diffusing capacity of the lung for carbon monoxide (DLCO; corrected) \>= 40% of predicted value * Left ventricular ejection fraction (LVEF) \>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) * Patients with Fridericia's corrected QT interval (QTcF) \> 450 ms for men and \> 470 ms for women will require clearance by a cardiologist * Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for 1 month after the last dose of study therapy (NKTR-255) * Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method for 1 month after the last dose of study therapy (NKTR-255) * Ability to understand and provide informed consent * Able and willing to comply with study visit schedule and procedures, including tumor biopsy where feasible and with acceptable risk Exclusion Criteria: * Planned use of therapeutic doses of corticosteroids (\> 20 mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to liso-cel infusion. Topical and/or inhaled steroids are permitted * Prior treatment with any CD19 CAR-T cell therapy * For allogeneic hematopoietic cell transplant (HCT) recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy within 30 days prior to planned leukapheresis * Known active hepatitis B (detectable hepatitis B deoxyribonucleic acid \[DNA\]) or hepatitis C (detectable hepatitis C ribonucleic acid \[RNA\]) * Known human immunodeficiency virus (HIV) infection * Pregnant or breastfeeding women * Prior treatment with any IL-2 or IL-15 agonist and/or biosimilar agents * Active autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome \[granulomatosis with polyangiitis\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) requiring immunosuppressive therapy. The following are exceptions to this criterion: * Vitiligo. * Alopecia. * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. * Type 1 diabetes mellitus. * Psoriasis not requiring systemic treatment. * Conditions considered to be low risk of serious deterioration by the principal investigator (PI). * History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina; unless clearance by a cardiologist is obtained. History of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to study treatment is also excluded * History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the PI is a contraindication to study treatment. * Patients with active parenchymal CNS involvement by malignancy will be excluded. Patients with prior or current secondary leptomeningeal CNS disease are eligible. CNS disease prophylaxis must be stopped at least 1 week prior to liso-cel infusion * History of solid organ transplantation * Active, serious, and uncontrolled infection(s)

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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

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.