NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma
Public ClinicalTrials.gov record NCT05664217. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Randomized, Double Blind, Placebo-controlled, Multicenter Study of NKTR-255 vs Placebo Following CD19-directed CAR-T Cell Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Chimeric antigen (CAR)-T cell product consists of genetically engineered T-cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.
Study identification
- NCT ID
- NCT05664217
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 15 participants
Conditions and interventions
Interventions
- NKTR-255 at 1.5 µg/kg Drug
- NKTR-255 at 3.0 μg/kg Drug
- NKTR-255 at 3.0/6.0 μg/kg Drug
- Placebo Comparator Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2022
- Primary completion
- May 21, 2024
- Completion
- Aug 15, 2024
- Last update posted
- Feb 12, 2025
2022 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 18
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| University Of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Novant Health Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Novant Health Cancer Institute - Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Oncology Hematology Care Inc - Cincinnati | Cincinnati | Ohio | 45236 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Intermountain Healthcare | Salt Lake City | Utah | 84143 | — |
| Fred Hutchinson/University of Washington | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05664217, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 12, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05664217 live on ClinicalTrials.gov.