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NCT05359211 · ClinicalTrials.gov registry record · Phase 1
NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
A Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by Fred Hutchinson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT05359211 is a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 27 participants, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05359211, a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 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. Lisocabtagene maraleucel is a CAR-T cell product that 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 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE X-Ray Imaging
- BIOLOGICAL Lisocabtagene Maraleucel
- DRUG Polymer-conjugated IL-15 Receptor Agonist NKTR-255
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2026-09-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05359211
The ClinicalTrials.gov registry entry for NCT05359211 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (43% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05359211 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05359211 about?
NCT05359211 is a clinical study titled "NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma". This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). NKTR-255 is an investigational IL-1...
What is the current status of trial NCT05359211?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-12-08. Estimated completion is 2026-09-04.
What conditions does trial NCT05359211 study?
This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Grade 3b Follicular Lymphoma, Refractory Grade 3b Follicular Lymphoma.
What interventions are being tested in trial NCT05359211?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), X-Ray Imaging (PROCEDURE), Lisocabtagene Maraleucel (BIOLOGICAL), Polymer-conjugated IL-15 Receptor Agonist NKTR-255 (DRUG).
Who is sponsoring clinical trial NCT05359211?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05359211 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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