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.
Nektar Study 18-255-01 was a Phase 2/3, randomized, double blind, placebo-controlled, multicenter study of NKTR-255 versus placebo following CD19-directed CAR-T cell therapy in patients with R/R LBCL. This study was to be run in 2 parts: Phase 2 (Stage 1) and Phase 3 (Stage 2). This study evaluated 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 was 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
- Feb 23, 2023 (Actual)
- Primary completion
- May 22, 2024 (Actual)
- Completion
- Aug 16, 2024 (Actual)
- Last update posted
- Oct 16, 2026
2023 – 2024
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Novant Health Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Oncology Hematology Care Inc - Cincinnati | Cincinnati | Ohio | 45236 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 Oct 16, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05664217 live on ClinicalTrials.gov.