Treatment (lymphodepletion, liso-cel, NKTR-255) for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Lymphoma+13 More
Lisocabtagene Maraleucel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Grade 3b Follicular Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Grade 3b Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Up to 21 days after the first NKTR-255 infusion

Day 30
Incidence of adverse events (AEs)
Month 12
Complete response (CR) and overall response (OR) rates
Duration of response (DOR)
Optimal biological dose (OBD)
Overall survival (OS)
Progression free survival (PFS)
Day 21
Dose-limiting toxicity (DLT) rates
Month 3
Complete response (CR) rate

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (lymphodepletion, liso-cel, NKTR-255)
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (lymphodepletion, liso-cel, NKTR-255) · No Placebo Group · Phase 1

Treatment (lymphodepletion, liso-cel, NKTR-255)Experimental Group · 4 Interventions: Lisocabtagene Maraleucel, Cyclophosphamide, Fludarabine, Polymer-conjugated IL-15 Receptor Agonist NKTR-255 · Intervention Types: Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~4020
Fludarabine
2012
Completed Phase 2
~1240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 days after the first nktr-255 infusion
Closest Location: Fred Hutch/University of Washington Cancer Consortium · Seattle, WA
Photo of Seattle  1Photo of Seattle  2Photo of Seattle  3
2018First Recorded Clinical Trial
57 TrialsResearching Lymphoma
140 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positron emission tomography (PET) scan or biopsy-proven active disease.
CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology.
Calculated creatinine clearance (Cockcroft/Gault) > 30 mL/min/1.
You must be at least 18 years of age to consent to this study.
You have a Karnofsky performance status of 60% or higher.
Platelets > 50,000 cells/mm^3 in the absence of bone marrow involvement by lymphoma.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.