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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 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. The trial reports 1 study location across 1 state.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07085338
The ClinicalTrials.gov registry entry for NCT07085338 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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