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NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

StatusCompleted
PhasePhase 1
Started2022-12-08
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial completed
2026-03-18
Study Status, Study Design v18
Enrollment target28→27
2025-09-08
Study Status, Document Section v17
Re-verified, no change to tracked fields
2025-08-26
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 24→confirmed 28
Study sitesdetails revised at 1 of 1 site
2025-07-08
Study Status v15
Primary completion date2025-06-30→2025-09-04
Completion date2026-06-30→2026-09-04
Show 14 earlier versions
2025-01-17
Study Status v14
Primary completion date2024-12-31→2025-06-30
Completion date2025-12-31→2026-06-30
2024-09-23
Study Status v13
Re-verified, no change to tracked fields
2024-02-02
Study Status v12
Primary completion date2024-01-31→2024-12-31
Completion date2024-12-31→2025-12-31
2024-01-02
Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria-18 characters
[...] disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) withinrequiring 1immunosuppressive year prior to the planned start of treatmenttherapy. The following are exceptions to this criterion: Vitiligo. [...]
Study sitescontacts updated at 1 of 1 site
2023-11-16
Study Status, Study Description, Conditions, Arms and Interventions v10
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), Lisocabtagene Maraleucel (Biological), Polymer-conjugated IL-15 Receptor Agonist NKTR-255…→Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed…
Study description+519 characters
[...] he absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray and echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients undergo bone marrow biopsy and aspiration, lumbar puncture (LP) for cerebrospinal fluid (CSF) sample collection during screening, on the study and during follow-up as clinically [...] After completion of study treatment, patients are followed up every 30 days for 3 months, then every 3 months up to 12 months after the CAR-T cell infusion.
2023-05-04
Study Status v9
Re-verified, no change to tracked fields
2023-02-13
Study Status, Eligibility, Contacts/Locations v8
Eligibility criteria-94 characters
Inclusion Criteria: Adult subjects with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) receiving liso-cel Male or female >= 18 years of age at the time of consent Pat [...]
Study sitescontacts updated at 1 of 1 site
2022-12-30
Study Status v7
Start dateestimated 2022-12-28→confirmed 2022-12-08
2022-11-28
Study Status v6
Start date2022-11-18→2022-12-28
2022-10-18
Study Status v5
Start date2022-10-20→2022-11-18
2022-09-20
Study Status v4
Start date2022-09-17→2022-10-20
2022-08-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2022-11-01→2022-09-17
Study sitesdetails revised at 1 of 1 site
2022-06-22
Study Status v2
Re-verified, no change to tracked fields
2022-05-02
Study Status v1
Start date2022-05-01→2022-11-01
2022-04-28
Original filing
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.
Trial Details
NCT Number NCT05359211
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Nektar Therapeutics
Conditions Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Grade 3b Follicular Lymphoma, Recurrent Primary Mediastinal Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory Grade 3b Follicular Lymphoma, Refractory Primary Mediastinal Large B-Cell Lymphoma +1 more
Enrollment 27 participants
Start Date 2022-12-08
Primary Completion 2025-09-04 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-21