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NCT06450041 · ClinicalTrials.gov registry record · Phase 2
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
A Phase 2 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 13
- Study locations
NCT06450041: Recruiting Phase 2 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT06450041 is a Phase 2 study of Neuroblastoma that is actively recruiting participants, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 62 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (74% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450041, a Phase 2 study of Neuroblastoma, is actively recruiting participants, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
Primary Outcome
The response evaluation is based on central review or site review (when central review is not available) of patient diagnostic assessments. Response is determined by the NANT response criteria v2.0 (https://doi.org/10.1002/pbc.26940). 1. Complete response 2. Partial response 3. Minor response 4. Stable response 5. Progressive disease 6. Early death from malignant disease 7. Early death from toxicity Evaluable response patients have received sufficient therapy (1) and have sufficient response ev
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG GM-CSF
- DRUG Dinutuximab
- DRUG Universal Donor (UD) TGFβi NK Cells
Study Locations (13)
California
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital - San Francisco
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Texas
- University of Texas Southwestern - Dallas
- Cook Children's Medical Center - Fort Worth
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Comer Children's Hospital, University of Chicago - Chicago
Massachusetts
- Boston Children's Hospital, Dana-Farber Cancer Institute. - Boston
Michigan
- C.S Mott Children's Hospital - Ann Arbor
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2038-12 |
| Phase | Phase 2 |
What NCT06450041 shows while recruiting
NCT06450041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT06450041 lists 13 locations in 10 states (California, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT06450041 about?
NCT06450041 is a clinical study titled "NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial". This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
What is the current status of trial NCT06450041?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2024-12-16. Estimated completion is 2038-12.
What conditions does trial NCT06450041 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT06450041?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), GM-CSF (DRUG), Dinutuximab (DRUG), Universal Donor (UD) TGFβi NK Cells (DRUG).
Who is sponsoring clinical trial NCT06450041?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450041 being conducted?
This trial has 13 study locations across California, Colorado, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06450041's enrollment target sits among peer trials
62 44th of 94 higher than 51 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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