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ACTIVE NOT RECRUITING
NCT05359211
PHASE1

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2022-12-08

Completion Date

2026-09-04

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Lisocabtagene Maraleucel

Given IV

DRUG

Polymer-conjugated IL-15 Receptor Agonist NKTR-255

Given IV

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Lumbar Puncture

Undergo LP

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

PROCEDURE

Biopsy

Undergo tissue biopsy

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States