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

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

• 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

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

Sponsors & Collaborators

• Nektar Therapeutics

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Alexandre Hirayama · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-08

Primary Completion

2025-09-04

Completion

2026-09-04

FDA Drug

Yes

Countries

• United States

Study Locations