OncRef

Clinical Trial: NCT05359211

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Fred Hutchinson Cancer Center
Information Provided By:Fred Hutchinson Cancer Center
Last Update Posted:2026-09-21

Study Overview

Brief 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.

Official Title

A Phase Ib Open-Label Study Evaluating the Safety and Efficacy of NKTR-255 in Combination With CD19-Directed CAR-T Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

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, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Intervention / Treatment

  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Biological: Lisocabtagene Maraleucel
  • Drug: Polymer-conjugated IL-15 Receptor Agonist NKTR-255
  • Procedure: X-Ray Imaging
  • Procedure: Echocardiography
  • Procedure: Multigated Acquisition Scan
  • Procedure: Bone Marrow Biopsy
  • Procedure: Bone Marrow Aspiration
  • Procedure: Lumbar Puncture
  • Procedure: Computed Tomography
  • Procedure: Positron Emission Tomography
  • Procedure: Biospecimen Collection
  • Procedure: Biopsy

Other Study ID Numbers

  • RG1122036
  • NCI-2022-02316
  • 10802

Start Date (Actual)

2022-12-08

Primary Completion Date (Actual)

2025-09-04

Study Completion Date (Actual)

2026-09-04

Enrollment (Actual)

27

Study Type

Interventional

Phase

Phase 1