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CAR T-cell Therapy

NKTR-255 + CAR-T Cell 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
Fludeoxyglucose F-18 (FDG)-avid disease on positron emission tomography (PET) imaging or pathology evidence of active disease
Left ventricular ejection fraction (LVEF) >= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 21 days after the first nktr-255 infusion
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Large B-Cell Lymphoma
  • B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are able to perform daily activities with at least 60% of your normal ability.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Computed Tomography
2017
Completed Phase 2
~2890
Echocardiography
2013
Completed Phase 4
~11670
Biopsy
2014
Completed Phase 4
~1160
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 1
~1540
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Lumbar Puncture
2016
Completed Phase 3
~510
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
551 Previous Clinical Trials
1,334,816 Total Patients Enrolled
Nektar TherapeuticsIndustry Sponsor
57 Previous Clinical Trials
10,208 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.
~4 spots leftby Jan 2024
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