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NCT07085338 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
A Phase 2 study of Neuroblastoma Recurrent, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT07085338: Recruiting Phase 2 study of Neuroblastoma Recurrent, sponsored by St. Jude Children's Research Hospital.
NCT07085338 is a Phase 2 study of Neuroblastoma Recurrent that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07085338, a Phase 2 study of Neuroblastoma Recurrent, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed). Primary Aims * To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable * To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF Secondary Aims * To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF * To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803
Primary Outcome
Feasibility Measures: Patients evaluable for toxicity in the safety run-in must receive one dose of N-803. The proportion of evaluable patients who successfully complete the protocol-defined treatment regimen in the Safety Run-in phase will be calculated. The reasons for treatment discontinuation or deviations from the protocol will be summarized.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Sargramostim
- DRUG hu14.18K322A
- DRUG N803
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-11-10 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
What NCT07085338 shows while recruiting
NCT07085338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Neuroblastoma Recurrent appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT07085338 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07085338 about?
NCT07085338 is a clinical study titled "A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma". The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed). Primary Aims * To evaluate if the administration of N...
What is the current status of trial NCT07085338?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2025-11-10. Estimated completion is 2029-02-01.
What conditions does trial NCT07085338 study?
This clinical trial studies the following conditions: Neuroblastoma Recurrent.
What interventions are being tested in trial NCT07085338?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Sargramostim (DRUG), hu14.18K322A (DRUG), N803 (DRUG).
Who is sponsoring clinical trial NCT07085338?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07085338 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT07085338's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 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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