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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

StatusRecruiting
PhasePhase 2
Started2025-11-10
View on ClinicalTrials.gov ↗

Amendment history

2026-08-06
Study Status, Contacts/Locations v10
Study sites4→5
2026-06-03
Study Status, Contacts/Locations v9
Study sites3→4
2026-05-28
Study Status, Contacts/Locations v8
Study sites1→3
2026-05-18
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2026-02-12
Study Status, Eligibility v6
Eligibility criteria+79 characters
[...] time prior to enrollment OR is MIBG avid on planar imaging. Patients with elevated catecholamines (i.e., > 2 x ULN) only are NOT eligible for this study. Performance Status - Patients must have Lansky (≤16 years) o [...] ed platelet or ANC counts) Concomitant Therapy Restrictions - Patients must not have received the concomitant medications indicated below within the specified time prior to study registrationenrollment or planned treatment start date on this study as follows: • [...] is permitted for patients with known adrenal insufficiency. • The use of dexamethasone as an antiemetic is not permitted. [...] es [...]
Show 5 earlier versions
2025-11-10
Study Status v5
Start dateestimated 2025-12→confirmed 2025-11-10
2025-10-24
Study Status, Eligibility v4
Eligibility criteria-174 characters
[...] ULN)], at the time of initial diagnosis. Disease Risk Group - Patients must have high-risk neuroblastoma according to COG [...] ligible. Response to Prior Therapy (using INRC definitions) - Patients must have at least ONE (recurrent/progressive, refr [...] purpose of assessing the performance score. Prior Therapy - Patients who have previously received anti-GD2 monoclonal antibodies are eligible unless they have had progressive disease while actively receiving prior anti-GD2. Patients must have fully recovered from the acute toxic effe [...] The use of dexamethasone as an antiemetic is not permitted. • Irinotecan [...] [...]
2025-10-23
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2025-10-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-08-02
Study Status, Study Description, Arms and Interventions, Eligibility v1
Start date2025-07→2025-12
Eligibility criteria-23 characters
[...] ollowing (lesions may have received prior radiation therapy as long asif they meet the other criteria listed below) based on institu [...] ved the therapies indicated below within the specified time period prior to registration on this study as follows: Table 2: Pri [...] mitant medications indicated below within the specified time period prior to study registration or planned treatment start date [...] s follows: • No other anti-cancer agents or radiotherapy at the time of study registration or while on study. • No short-act [...] ased tumors with direct intracranial extension are eligible as long asif there are no neur [...] [...]
Study description-380 characters
[...] ive irinotecan, temozolomide, hu14.18K322A, GM-CSF and N-803 (20 mcg/kg). If fewer than 2 patients in the first cohort of 6 patients experience a DLT in Cycle 1, then the trial will proceed to the Phase 2. If 2 or more of the first 6 patients experience a DLT in Cycle 1 then the N-803 will be dose reduced to 15 mcg/kg, and 6 more patients will be enrolled in the safety assessme [...] ndomized to receive either chemoimmunotherapy alone (Arm A) versusor chemoimmunotherapy plus N-803 (Arm B). Patients treated on [...] tive biology studies will be performed throughout the study. Disease evaluations should be p [...]
2025-07-17
Original filing
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
Trial Details
NCT Number NCT07085338
Lead Sponsor St. Jude Children's Research Hospital
Conditions Neuroblastoma Recurrent
Enrollment 54 participants
Start Date 2025-11-10
Primary Completion 2028-02-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07