Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by Fred Hutchinson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Grade ≥ 3 AEs considered related to NKTR-255 will be listed and summarized. Summaries of grade ≥ 3 laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the safety evaluable population.
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 |
What the registry record for NCT05359211 still lists
NCT05359211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (43% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Diffuse Large B-Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05359211's enrollment target sits among peer trials
27 27th of 43 higher than 15 of 43 other Recurrent Diffuse Large B-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Diffuse Large B-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
RECRUITING · Phase 1
-
Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
RECRUITING · Phase 1
-
B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies
RECRUITING · Phase 1
-
Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI