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NCT05664217 · ClinicalTrials.gov registry record · Phase 2

NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

A Phase 2 study, sponsored by Nektar Therapeutics.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT05664217: Clinical Trial Phase 2 study, sponsored by Nektar Therapeutics.

NCT05664217 is a Phase 2 study that was terminated before completion, run by Nektar Therapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05664217, a Phase 2 study, was terminated before completion, sponsored by Nektar Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). 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. Chimeric antigen (CAR)-T cell product 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 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.

Primary Outcome

The incidence of complete response by the Lugano Classification (Cheson et al, 2014) as determined by blinded independent central review (BICR)

Interventions

  • OTHER Placebo Comparator
  • DRUG NKTR-255 at 1.5 µg/kg
  • DRUG NKTR-255 at 3.0 μg/kg
  • DRUG NKTR-255 at 3.0/6.0 μg/kg

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2022-12-23
Est. Completion 2024-08-16
Phase Phase 2
Nektar Therapeutics

37 total trials

Why NCT05664217 stopped before completion

NCT05664217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo Comparator is the first listed.

NCT05664217 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05664217 about?

NCT05664217 is a clinical study titled "NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma". This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ...

What is the current status of trial NCT05664217?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2022-12-23. Estimated completion is 2024-08-16.

What interventions are being tested in trial NCT05664217?

The interventions under investigation include: Placebo Comparator (OTHER), NKTR-255 at 1.5 µg/kg (DRUG), NKTR-255 at 3.0 μg/kg (DRUG), NKTR-255 at 3.0/6.0 μg/kg (DRUG).

Who is sponsoring clinical trial NCT05664217?

This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05664217's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05664217, the US trial registry maintained by the National Library of Medicine. NCT05664217 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.