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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: Recruiting Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, sponsored by Nationwide Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with treatment-related adverse events and toxicities as assessed by CTCAE v4.0
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Sargramostim
- BIOLOGICAL Natural Killer Cells
- DRUG Dinutuximab
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT04211675 shows while recruiting
NCT04211675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 49-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (37% lower).
The record links to 2 conditions, with Refractory Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT04211675 reports a single indexed study location in 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: Temozolomide (DRUG), Irinotecan (DRUG), Sargramostim (DRUG), Natural Killer Cells (BIOLOGICAL), Dinutuximab (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.
Learn More About Clinical Trials
Similar trials for Refractory Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04211675's enrollment target sits among peer trials
31 7th of 9 higher than 3 of 9 other Refractory Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Neuroblastoma 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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