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NCT04211675 · ClinicalTrials.gov registry record · Phase 1

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

A Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, sponsored by Nationwide Children's Hospital.

Recruiting
Registry status
Phase 1
Development phase
31
Enrollment target
1
Study location

NCT04211675 is a Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 31 participants, below the 49-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04211675, a Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.

RECRUITING
Registry status
Phase 1
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.

Interventions

  • BIOLOGICAL Natural Killer Cells
  • DRUG Temozolomide
  • DRUG Irinotecan
  • DRUG Dinutuximab
  • DRUG Sargramostim

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2022-09-01
Est. Completion 2027-12
Phase Phase 1

Sponsor

Nationwide Children's Hospital

188 total trials

What the Registry Record Tells You About NCT04211675

The ClinicalTrials.gov registry entry for NCT04211675 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 49-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (37% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Refractory Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Natural Killer Cells is the first listed.

NCT04211675 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT04211675 about?

NCT04211675 is a clinical study titled "NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab". This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.

What is the current status of trial NCT04211675?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-09-01. Estimated completion is 2027-12.

What conditions does trial NCT04211675 study?

This clinical trial studies the following conditions: Refractory Neuroblastoma, Relapsed Neuroblastoma.

What interventions are being tested in trial NCT04211675?

The interventions under investigation include: Natural Killer Cells (BIOLOGICAL), Temozolomide (DRUG), Irinotecan (DRUG), Dinutuximab (DRUG), Sargramostim (DRUG).

Who is sponsoring clinical trial NCT04211675?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04211675 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.