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NCT05400603 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma
A Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05400603: Recruiting Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, sponsored by Emory University.
NCT05400603 is a Phase 1 study of Neuroblastoma and Refractory Neuroblastoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 24 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05400603, a Phase 1 study of Neuroblastoma and Refractory Neuroblastoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate
Primary Outcome
The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event (AE) reporting. The MTD/RP2D is defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity course
Conditions Studied
Interventions
- COMBINATION_PRODUCT Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-11-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05400603 shows while recruiting
NCT05400603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate is the first listed.
NCT05400603 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05400603 about?
NCT05400603 is a clinical study titled "Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma". The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ rel...
What is the current status of trial NCT05400603?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-11-06. Estimated completion is 2026-12.
What conditions does trial NCT05400603 study?
This clinical trial studies the following conditions: Neuroblastoma, Refractory Neuroblastoma, Relapsed Neuroblastoma, Refractory Osteosarcoma, Relapsed Osteosarcoma.
What interventions are being tested in trial NCT05400603?
The interventions under investigation include: Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05400603?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05400603 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT05400603's enrollment target sits among peer trials
24 67th of 94 higher than 27 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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