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CAR T-cell Therapy

NKTR-255 + CAR-T Therapy for Large B-cell Lymphoma

Phase 1

Recruiting

Led By Alexandre Hirayama

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology

Platelets >= 50,000 cells/mm^3 in the absence of bone marrow involvement by lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 days after the first nktr-255 infusion

Awards & highlights

Study Summary

This trial is testing the combination of NKTR-255 and CAR-T cell therapy to treat patients with large B-cell lymphoma that has relapsed or is refractory.

Who is the study for?

Adults with relapsed or refractory large B-cell lymphoma eligible for CAR-T therapy, who have a Karnofsky performance status of at least 60%, proper heart function (LVEF >= 40%), and adequate blood counts. They must not have active central nervous system involvement by malignancy, serious infections, HIV, history of solid organ transplant, recent use of systemic steroids or immunosuppression, prior CD19 CAR-T cell therapy or IL-15 agonist treatment.Check my eligibility

What is being tested?

This trial is testing NKTR-255 combined with lisocabtagene maraleucel (a type of CAR-T cell therapy) to see if it's more effective in treating large B-cell lymphoma than standard treatments. NKTR-255 aims to enhance the immune response against cancer cells while lisocabtagene maraleucel targets CD19 on cancer cells.See study design

What are the potential side effects?

Potential side effects include reactions related to boosting the immune system which may cause fever, fatigue, and flu-like symptoms; complications from genetically engineered T-cells such as difficulty breathing or allergic reactions; and typical chemotherapy-related issues like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows or is likely to show CD19 expression.

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My platelet count is at least 50,000 without lymphoma in my bone marrow.

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I understand the study and can give my consent.

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My white blood cell count is healthy without lymphoma affecting my bone marrow.

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I experience mild or no shortness of breath.

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I can care for myself but may need occasional help.

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I have a type of large B-cell lymphoma approved for liso-cel treatment.

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My lung function is at least half of what is expected for someone my age and size.

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My scans show active cancer.

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I am willing and able to follow the study's schedule and procedures, including getting a tumor biopsy if it's safe.

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My lung function test shows at least 40% of the normal value.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days after the first nktr-255 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 days after the first nktr-255 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days after the first nktr-255 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete response (CR) rate

Dose-limiting toxicity (DLT) rates

Incidence of adverse events (AEs)

+1 more

Secondary outcome measures

Complete response (CR) and overall response (OR) rates

Duration of response (DOR)

Overall survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lymphodepletion, liso-cel, NKTR-255)Experimental Treatment14 Interventions

Patients receive standard of care lymphodepletion therapy consisting of cyclophosphamide and fludarabine on days -5 to -3 followed by liso-cel CAR-T cell infusion on day 0. Patients then receive NKTR-255 IV over 30 minutes every 3 weeks starting on day 10 or 14 for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray and ECHO or MUGA during screening. Patients undergo bone marrow biopsy and aspiration, LP for CSF sample collection during screening, on the study and during follow-up as clinically indicated. Patients also undergo PET/CT throughout the trial. Additionally, patients undergo blood sample collection and may optionally undergo tissue biopsy throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Lumbar Puncture

2016

Completed Phase 3

~510

Biopsy

2014

Completed Phase 4

~1090

Positron Emission Tomography

2008

Completed Phase 2

~2240

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,244 Total Patients Enrolled

Nektar TherapeuticsIndustry Sponsor

58 Previous Clinical Trials

10,318 Total Patients Enrolled

Alexandre HirayamaPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Lisocabtagene Maraleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05359211 — Phase 1

B-Cell Lymphoma Research Study Groups: Treatment (lymphodepletion, liso-cel, NKTR-255)

B-Cell Lymphoma Clinical Trial 2023: Lisocabtagene Maraleucel Highlights & Side Effects. Trial Name: NCT05359211 — Phase 1

Lisocabtagene Maraleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359211 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given clearance for Polymer-conjugated IL-15 Receptor Agonist NKTR-255?

"Since this is an early-stage trial, the safety of Polymer-conjugated IL-15 Receptor Agonist NKTR-255 has been assessed as a 1 on our scale at Power due to scant evidence regarding its efficacy and protection."

Answered by AI

How many individuals have been accepted to participate in this experiment?

"Affirmative, the clinicaltrial.gov portal supports that this trial is soliciting patients at present date. The study was initially made public on December 28th 2022 and revised lastly on November 28th 2022. 24 individuals are targeted for recruitment from a single site."

Answered by AI

Are there available slots for participants in this research program?

"Indeed, the data on clinicaltrials.gov confirms that this scientific trial is still recruiting participants. The posting was first uploaded to the website in December 28th 2022 and underwent its last update on November 28th 2022. 24 individuals across 1 site are needed for successful completion of this research endeavour."

Answered by AI

What is the aim of this research endeavor?

"According to Nektar Therapeutics, the primary outcome of this clinical trial will be ascertained over a 12-month period following CAR-T cell infusion. This efficacy evaluable population will have its complete response (CR) rate and overall response (OR) rates measured with Kaplan-Meier analysis, in addition to secondary outcomes such as duration of response which is estimated through censoring events or last contact/follow up visits. The safety population's overall survival (OS) is also analyzed using KM method for assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359211.